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Showing 1801–1820 of 8389 results

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8MM Horizon Small Clip Applier (Intuitive Surgical) – Grip Cable Failure (2024)

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

FDADec 19, 2024AL, AK, AZ +49 more• Intuitive Surgical, Inc.

8MM Small Grasping Retractor (Intuitive Surgical) – Grip Cable Failure (2024)

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

FDADec 19, 2024AL, AK, AZ +49 more• Intuitive Surgical, Inc.

KARL STORZ Uretero-Renoscope (Karl Storz) – Reprocessing Modality Issue (2024)

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Moderate

FDADec 19, 2024Nationwide• Karl Storz Endoscopy

KARL STORZ Uretero-Renoscope (Karl Storz) – Reprocessing Modality Issue (2024)

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

FDADec 19, 2024Nationwide• Karl Storz Endoscopy

KARL STORZ Pediatric Uretero-Renoscope (Karl Storz) – Reprocessing Issue (2024)

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

FDADec 19, 2024Nationwide• Karl Storz Endoscopy

8MM Potts Scissors (Intuitive Surgical) – Grip Cable Failure (2024)

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

FDADec 19, 2024AL, AK, AZ +49 more• Intuitive Surgical, Inc.

8MM Large SutureCut Needle Driver (Intuitive Surgical) – Grip Cable Failure (2024)

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

FDADec 19, 2024AL, AK, AZ +49 more• Intuitive Surgical, Inc.

8MM Atrial Retractor (Intuitive Surgical) – Grip Cable Failure (2024)

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

FDADec 19, 2024AL, AK, AZ +49 more• Intuitive Surgical, Inc.

8MM Fenestrated Bipolar Forceps (Intuitive Surgical) – Grip Cable Failure (2024)

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

FDADec 19, 2024AL, AK, AZ +49 more• Intuitive Surgical, Inc.

8MM Long Bipolar Grasper (Intuitive Surgical) – Grip Cable Failure (2024)

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

FDADec 19, 2024AL, AK, AZ +49 more• Intuitive Surgical, Inc.

8MM Round Tip Scissors (Intuitive Surgical) – Grip Cable Failure (2024)

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

FDADec 19, 2024AL, AK, AZ +49 more• Intuitive Surgical, Inc.

8MM Long Tip Forceps (Intuitive Surgical) – Grip Cable Failure (2024)

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

FDADec 19, 2024AL, AK, AZ +49 more• Intuitive Surgical, Inc.

8MM Cadiere Forceps (Intuitive Surgical) – Grip Cable Failure (2024)

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

FDADec 19, 2024AL, AK, AZ +49 more• Intuitive Surgical, Inc.

8MM Resano Forceps (Intuitive Surgical) – Grip Cable Failure (2024)

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

FDADec 19, 2024AL, AK, AZ +49 more• Intuitive Surgical, Inc.

KARL STORZ Uretero-Renoscope (Karl Storz) – Reprocessing Modality Issue (2024)

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

FDADec 19, 2024Nationwide• Karl Storz Endoscopy

8MM Small Graptor (Intuitive Surgical) – Pitch Cable Failure (2024)

Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments

FDADec 19, 2024Nationwide• Intuitive Surgical, Inc.

8MM Tenaculum Forceps (Intuitive Surgical) – Grip Cable Failure (2024)

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

FDADec 19, 2024AL, AK, AZ +49 more• Intuitive Surgical, Inc.

8MM Cobra Grasper (Intuitive Surgical) – Grip Cable Failure (2024)

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

FDADec 19, 2024AL, AK, AZ +49 more• Intuitive Surgical, Inc.

8MM ProGrasp Forceps (Intuitive Surgical) – Grip Cable Failure (2024)

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

FDADec 19, 2024AL, AK, AZ +49 more• Intuitive Surgical, Inc.

Karl Storz Endoskope Biopsy Forceps (Karl Storz) – Cleaning Validation Failure (2024)

Due to failure of manual cleaning validation, biopsy and grasping forceps like sterility assurance.

FDADec 19, 2024AZ, AR, CA +29 more• Karl Storz Endoscopy

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