MAUDE Adverse Event Report: KARL STORZ SE & CO. KG TENACULUM GRASPING FORCEPS, 34 CM

Model Number	26159H
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.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.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that the distal end of the instrument became loose during procedure.A thorough inspection using the hysteroscope was done to check any retained suspected components of the instrument.Then, an ultrasound and ct scan were done for further inspection.A screw approximately 0.5mm in size was discovered in the vaginal canal.It remains unclear if the screw could be removed or not.The overall procedure was completed successfully with a spare device and a surgical prolongation between 15 and 60 minutes.
Additional Manufacturer Narrative
Result of investigation: the connecting rivet has come loose/broken in the joint on the distal side.The item was produced in 2022, so it can be assumed that it has been used or refurbished correspondingly often.Corrosion can be seen on the joint surfaces, a sign that the item was not dried properly after preparation.The rivet has become detached/broken from the joint parts.In addition, the two jaw parts are bent apart, but these should slide past each other.The probable cause of this damage is due to mechanical impact by the user.The two jaw parts have bent apart due to torsional forces; the forces have placed too high load on the connecting rivet, causing damage.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: TENACULUM GRASPING FORCEPS, 34 CM
• Common Device Name: TENACULUM GRASPING 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: 21149418
• Report Number: 9610617-2025-00024
• Device Sequence Number: 9189828
• Product Code: GCJ
• UDI-Device Identifier: 04048551094341
• UDI-Public: 04048551094341
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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): 03/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 26159H
• Device Catalogue Number: 26159H
• Device Lot Number: WN03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2025
• Supplement Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 03/06/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown