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

Model Number	26159UHW
Medical Device Problem Codes	Break (1069); 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
Device evaluation: accordingly, we would like to give a summary of our results regarding the reported issue.The device has not been returned to karl storz tuttlingen.The supplier carried out an investigation without returning goods.According to the related 8d report the rivet has come loose because the weld on the jaw part is not deep enough and the countersink is too small.The employee did not countersink correctly.The corresponding operating instructions ri: 26159uhw_en_v48.3_03-2023_ri_ce refer to a visual and functional inspection of the device on pages 13 and 15.The operating instructions 97000045 v2.0 - 10/2017 state that overloading should be avoided, see page 2.The event is filed under internal karl storz complaint id: (b)(6).
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that at the time of carrying out the procedure, the clamp broke.But there is conflicting information that indicates this happened before the surgery.No negative impact in state of health reported.
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).
Additional Manufacturer Narrative
Device evaluation: during the technical investigation of the returned product, the following observations were made: it was determined that the rivet had loosened due to an undersized countersink on the jaw component combined with an insufficient weld depth.The relevant ifu specify that the device should undergo both visual and functional inspections and emphasize that overloading must be avoided.The event is filed under internal karl storz complaint id: (b)(4).

• 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: 21470505
• Report Number: 9610617-2025-00319
• Device Sequence Number: 14305276
• Product Code: GCJ
• UDI-Device Identifier: 04048551094495
• UDI-Public: 04048551094495
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 12/02/2025

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: 26159UHW
• Device Catalogue Number: 26159UHW
• Device Lot Number: YN08
• 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: 02/12/2025
• Supplement Date Received by Manufacturer: 05/21/2025; 06/18/2025; 11/06/2025
• Initial Report FDA Received Date: 02/26/2025
• Supplement Report FDA Received Date: 05/30/2025; 07/16/2025; 12/02/2025
• 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