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)
Date of Event	10/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during gynecologic hysteroscopic surgery, the connection part of the jaw broke while the product was being used as a hystero sheath working channel to collect a lesion.The hospital staff do not know where the missing part has fallen or if x-rays were taken.The procedure was successfully completed with a surgical delay of less than 15 minutes.No negative impact in state of health reported.
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).
Additional Manufacturer Narrative
Result of investigation: it must be assumed that the user has caused a mechanical overload.The connecting rivet in a joint part has been sheared off, the welded side is still visible and is still in the joint part.On the opposite side, the sheared part with the rivet head is missing.The reason for this may be that excessive force was exerted on the joint.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, 5 FR.
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr,-kark - storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr,-kark - storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 20569731
• Report Number: 9610617-2024-00427
• Device Sequence Number: 7827358
• Product Code: GCJ
• UDI-Device Identifier: 04048551094242
• UDI-Public: 04048551094242
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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
• Report Date (Section B): 11/25/2024

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: 10/16/2024
• Supplement Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 11/26/2024
• 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