MAUDE Adverse Event Report: KARL STORZ SE & CO. KG BIOPSY AND GRASPING FORCEPS, 5 FR.

Model Number	26160UHW
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the event description "wire broken" prior procedure.No negative impact in state of health reported.
Additional Manufacturer Narrative
Additional information is provided in section d9 to reflect that the product was returned for evaluation.The investigation is not completed yet.The investigation results are pending.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Correction g2: foreign selected.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Correction: this mdr is being retracted.A total of 3 devices were used from article 011050-10 which is a package of 10.Mdr 9610617-2025-00829 was filed to capture 3 devices used from this package of 10.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Result of investigation: the connecting rivet of the forceps has come loose in the joint on the distal side.The manufacturer's 8d report identifies several root causes for the issue.Firstly, the rivet came loose.This was due to the weld on the jaw part not being deep enough.Additionally, the countersink on the jaw part was too small, and the employee did not perform the countersinking process correctly.The corresponding operating instructions refer to a visual and functional inspection of the device and that overloading should be avoided.Supplemental 1 of this mdr 9610617-2025-00836 to retract the initial mdr was submitted in error.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported "display defect".No negative impact in state of health reported.

• Brand Name: BIOPSY AND GRASPING FORCEPS, 5 FR.
• Common Device Name: BIOPSY AND GRASPING FORCEPS, 5 FR.
• 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: 22015685
• Report Number: 9610617-2025-00836
• Device Sequence Number: 9411709
• Product Code: GCJ
• UDI-Device Identifier: 04048551094679
• UDI-Public: 04048551094679
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K934937
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/31/2025

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 Model Number: 26160UHW
• Device Catalogue Number: 26160UHW
• Device Lot Number: ZL01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2025
• Supplement Date Received by Manufacturer: 05/29/2025; 05/27/2025; 10/22/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 05/29/2025; 06/02/2025; 10/30/2025
• 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