MAUDE Adverse Event Report: KARL STORZ SE & Co. KG Biopsy Spoon Forceps, 5 Fr.

Model Number	26159BHW
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported: during hysteroscopic surgery in the department of gynecology, forceps model 26159bhw were used for the procedure.The forceps functioned properly for the first several uses, but failed to open upon subsequent use.The forceps were removed from the uterine cavity for examination, and the jaw screw of the forceps was found missing.The physician suspected that the fallen screw might remain inside the patient's body; therefore, hysteroscopic exploration was performed, yet the missing screw was not located.Nevertheless, the physician considered there remained a risk that the screw could be retained within the uterine cavity, hence this report was submitted.
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).

• Brand Name: Biopsy Spoon Forceps, 5 Fr.
• Common Device Name: Biopsy Spoon Forceps, 5 Fr.
• 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: theresa mussaw ; 2151 e grand ave; el segundo, CA 90245 ; +1(410)441-1327
• MDR Report Key: 50487502
• Report Number: 9610617-2026-02049
• Device Sequence Number: 10395844
• Product Code: GCJ
• UDI-Device Identifier: 04048551094242
• UDI-Public: 04048551094242
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K934937
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2026

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: 26159BHW
• Device Catalogue Number: 26159BHW
• Device Lot Number: NL02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2026
• Supplement Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 08/27/2026
• Supplement Report FDA Received Date: 08/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Required Intervention; Other
• Patient Sex: Unknown