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

Model Number	26159UHW
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not returned at the time of mdr submission.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
According to the information received, device used to perform an operative hysteroscopy with endometrial biopsy.The device has contact with the patient for approximately 2 minutes and the total procedure duration was approximately 10 minutes.The patient attends the hysteroscopy clinic for follow-up of endometrial hyperplasia without atypia.During the performance of the hysteroscopy with a bettocchi hysteroscope, using biopsy forceps, the forceps does not close and a small metal screw was found in the uterine cavity (probably detached from the forceps that did not close).An attempt to recover the screw with new forceps failed.At the end of the examination, the screw was not found in the uterine cavity or in the lumbar collection bag.The patient was informed of what had happened.

• Brand Name: BIOPSY AND GRASPING FORCEPS, 5 FR.
• Common Device Name: BIOPSY AND GRASPING FORCEPS, 5 FR.
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 23595739
• Report Number: 2020550-2025-02110
• Device Sequence Number: 10380594
• Product Code: GCJ
• UDI-Device Identifier: 04048551094495
• UDI-Public: 04048551094495
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 11/19/2025
• Report Date (Section F): 11/19/2025

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: 26159UHW
• Device Catalogue Number: 26159UHW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/03/2025
• Event Location: Hospital
• Date Report to Manufacturer: 11/19/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/19/2025
• 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