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

Model Number	26159UHW
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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
It was reported that during a diagnostic hysteroscopy, a component (ball/joint) became detached from the distal tip of the instrument.This occurred during normal use.The procedure was aborted when the metal part of the instrument was lost.It was spent the remaining time attempting to locate and retrieve it.A ct scan of the abdomen was done to locate the fragment, which took more than 30 minutes - but without success.A ct scan is planned to locate the broken part.The patient was informed about the incident and is feeling anxious and worried.

• 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: 24867181
• Report Number: 2020550-2026-00815
• Device Sequence Number: 13391252
• Product Code: GCJ
• UDI-Device Identifier: 04048551094495
• UDI-Public: 04048551094495
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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): 04/13/2026
• Report Date (Section F): 04/13/2026

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
• Device Lot Number: RN02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/30/2026
• Event Location: Hospital
• Date Report to Manufacturer: 04/13/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/13/2026
• 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: Required Intervention; Other
• Patient Sex: Unknown