MAUDE Adverse Event Report: KARL STORZ SE & CO. KG OPTICAL FORCEPS, FOR BIOPSY

Catalog Number	27072A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.Pending further results a supplemental report will be filed.The event is filed under internal (b)(4) complaint id: (b)(4).
Event or Problem Description
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
This report is to correct section d9 from the last supplemental report that was submitted.The device was returned on april 17, 2023, not may 5, 2023.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
It was determined that the claimed item 27072a was damaged by excessive force.Excessive force was exerted on the joint where the broken axle pin was mounted.Here, the bore has been thrown up and a deformation of the bore is visible.This happens when, for example, tissue/cartilage or similar is held/punched in the jaw, this material is too tough/hard, and one tries to close the jaw with excessive force through the handle anyway, then the axle pin presses against the hole so long and powerfully until a throw-up occurs or until the pin gives way and breaks.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: OPTICAL FORCEPS, FOR BIOPSY
• Common Device Name: OPTICAL FORCEPS, FOR BIOPSY
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: christiane klaiber ; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 16761493
• Report Number: 9610617-2023-00081
• Device Sequence Number: 6034324
• Product Code: OCZ
• UDI-Device Identifier: 04048551079157
• UDI-Public: 4048551079157
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K950434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 27072A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2023
• Supplement Date Received by Manufacturer: 05/15/2023; 05/15/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 05/15/2023; 05/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown