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

Model Number	27072A
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that during procedure jaws broke and locking ring pin detached.No negative impact in state of health reported.
Additional Manufacturer Narrative
Device evaluation: technical investigation revealed the following: a broken joint part was detected in the distal joint part.This could be caused by overloading, corrosion or aging of the device.The broken parts were not included in the return shipment of the device.A broken pin was also foun in the proximal handle part.This broken part is included.Breakage is also most probably due to overloading, corrosion or aging of the device.All in all the device shows signs of corrosion, which could be the result of improper reprocessing.Based on the production date of (b)(6) 2017 it can be assumed that product aging, reconditioning cycles and corrosion weakened the broken parts in the distal and proximal area, causing it to break under load.Apprpriate warnings are included in the instructions for use under chapter 4 and 9 for correct handling and visual inspection of the device.Also the correct reprocessing and care is described in chapter 5 of the corresponding reprocessing instructions.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 (Section G): KARL STORZ SE & CO. KG; dr.-karl storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 22993913
• Report Number: 9610617-2025-01563
• Device Sequence Number: 21050026
• Product Code: OCZ
• UDI-Device Identifier: 04048551079157
• UDI-Public: 04048551079157
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K243653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2026

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: Other
• Device Model Number: 27072A
• Device Catalogue Number: 27072A
• Device Lot Number: NS18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2025
• Supplement Date Received by Manufacturer: 01/19/2026
• Initial Report FDA Received Date: 09/08/2025
• Supplement Report FDA Received Date: 03/19/2026
• 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