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

Model Number	26159BHW
Medical Device Problem Code	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 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 gynecologic hysteroscopic surgery, the connection part of the jaw part failed when the product was used as hystero sheath working channel to collect lesions.The surgery was prolonged for less than 15 minutes.After the surgery the product was returned to the local subsidiary and inspected.It was discovered that a bar-like part connecting two sections of the square box was missing.No harm on patient or negative impact in state of health reported.Because of the uncertain information if the fallen off connection part was left in the patient a report to the fda is required as a precautionary measure.
Additional Manufacturer Narrative
During the technical inspection of the returned product, the following was found: most probable root cause: mechanical overloading by the operator the two weld seams on the back of the rivets in the joint of the jaw are broken.This has caused both rivets to fly out of the joint.The reason for this may be that excessive force was applied to the joint.This is also indicated by the deformed cutting edge (fig 3), which has been bent, for example, by gripping a hard object.The corresponding reprocessing instruction 26159bhw_en_v48.2_03-2023_ri_ce indicates a visual inspection and functional check for the device.In addition the instructions for use 97000045 v2.0 - 10/2017 lists a warning not to overload the instrument as it may cause the medical device to break, bend and malfunction and consequently injure the patient or user.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: 20429794
• Report Number: 9610617-2024-00380
• Device Sequence Number: 18039822
• 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
• Report Date (Section B): 10/12/2024

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?: No
• 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: 09/27/2024
• Supplement Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 10/11/2024
• Supplement Report FDA Received Date: 11/12/2024
• 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