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.

• 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
• MDR Report Key: 21149417
• Report Number: 2020550-2025-00024
• Device Sequence Number: 9189827
• Product Code: GCJ
• UDI-Device Identifier: 04048551094341
• UDI-Public: 04048551094341
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/14/2025
• Report Date (Section F): 01/14/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/10/2025
• Event Location: Hospital
• Date Report to Manufacturer: 01/14/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/14/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown