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

Catalog Number 27072A

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/31/2023

Event Type  malfunction  

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 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.

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).

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
• Type of Device: 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
• MDR Text Key: 313509117
• Report Number: 9610617-2023-00081
• Device Sequence Number: 1
• Product Code: OCZ
• UDI-Device Identifier: 04048551079157
• UDI-Public: 4048551079157
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K950434
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 27072A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1