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

Model Number	26159BHW
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
The device in question was returned to the manufacturer on january 14,2025.This information is reflected in section d9.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.This event is filed under internal complaint id: (b)(4).
Event or Problem Description
It was reported that the distal tip fall off, always.During the technical inspection it was determined that the pin from the distal joint is missing.There is no information that the event caused a harm or serious injury to patient.
Additional Manufacturer Narrative
Device evaluation: during the investigation of the returned product, the following was found: it was detected that the "rivet" has come loose cause by a not deep enough weld on the jaw part.This was caused by a manufacturing deficiency.The corresponding operating instructions ri: 26159bhw_en_v48.2_03-2023_ri_ce refer to a visual and functional inspection of the device on pages 14 and 16.The operating instructions 97000045 v2.0 - 10/2017 state that overloading should be avoided, this event is filed under internal complaint id: (b)(4).

• Brand Name: BIOPSY SPOON FORCEPS, 5 FR.
• Common Device Name: BIOPSY SPOON 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: 21345398
• Report Number: 9610617-2025-00174
• Device Sequence Number: 15443537
• Product Code: GCJ
• UDI-Device Identifier: 04048551094242
• UDI-Public: 04048551094242
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 10/27/2025

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: 26159BHW
• Device Catalogue Number: 26159BHW
• Device Lot Number: XM02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2025
• Supplement Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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