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

Model Number	26159BHW
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2024
Type of Reportable Event	Malfunction
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
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 during a hysteroscopy procedure in the obstetrics and gynecology department, an issue occurred while using the device to collect tissue samples from a lesion.The connecting part of the jaw experienced a failure, causing the pin to detach.As a result, there was a roughly one-hour process to locate the pin within the patient's body, and it was successfully retrieved.It was confirmed that the procedure was completed successfully and there were no adverse consequences for the patient.Since the procedure had to be prolonged by roughly one-hour to locate the pin within the patient's body, this case is deemed reportable as a precautionary action.
Additional Manufacturer Narrative
Result of investigation: during investigation of the returned instrument it could be confirmed that a connecting rivet has come loose in the joint on the distal side.It was determined that this is due to a manufacturing defect.The weld seam on the back part was not deep enough because the hole was not drilled deep enough.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: BIOPSY SPOON FORCEPS, 5 FR.
• Common Device Name: BIOPSY SPOON FORCEPS
• 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: 20642574
• Report Number: 9610617-2024-00445
• Device Sequence Number: 7471242
• Product Code: GCJ
• UDI-Device Identifier: 04048551094242
• UDI-Public: 04048551094242
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/01/2025

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: SL01
• 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: 10/25/2024
• Supplement Date Received by Manufacturer: 11/20/2024; 07/30/2025
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 12/10/2024; 08/01/2025
• 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