MalfunctionOCZ

OPTICAL FORCEPS, FOR BIOPSY

Received Apr 18, 2023 · Event occurred Mar 31, 2023

Report 2020550-2023-00081 · MDR key 16761420

Device

Generic name

Endoscopic Firceps, Biopsy, Rigid

Manufacturer

Karl Storz Endoscopy-america, Inc.

Catalog number

27072A

Product problems

Break
Break

Patient

Unknown

No Clinical Signs, Symptoms or Conditions
No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

THE EVENT OCCURRED IN GREAT BRITAIN. IT WAS REPORTED THAT THE INSTRUMENT FAILED DURING USE. A RIVET FELL OUT. THE RIVET WAS RETRIEVED DURING THE PROCEDURE.

Additional Manufacturer Narrative

THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4). PENDING FURTHER RESULTS A SUPPLEMENTAL REPORT WILL BE FILED.