MAUDE Adverse Event Report: KARL STORZ SE & CO. KG TAKE-APART FORCEPS INSERT, 5MM, 33CM

Model Number	26176HT
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that "the vet has started cauterizing the first side, got halfway through and it stopped working.We changed diathermy unit and tried 3 different cables, and it still didn't work.We then tried our different cauterizing instrument, and it worked.They had a spare take-apart bipolar forceps that was unsterile and had to be sterilized again.The procedure took 3 hours as opposed to the usual one and a half hours".No negative impact in state of health reported.
Additional Manufacturer Narrative
The issue occurred during use in a veterinary procedure, and no adverse health effects were reported in any human.However, out of an abundance of caution, we will report this event, as we also market similar devices intended for human use.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: TAKE-APART FORCEPS INSERT, 5MM, 33CM
• Common Device Name: TAKE-APART FORCEPS INSERT, 5MM, 33CM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen 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: 25451610
• Report Number: 9610617-2026-01342
• Device Sequence Number: 10450473
• Product Code: HET
• UDI-Device Identifier: 04048551100059
• UDI-Public: 04048551100059
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K953809
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 26176HT
• Device Catalogue Number: 26176HT
• Device Lot Number: TK01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2026
• Supplement Date Received by Manufacturer: 06/09/2026; 06/12/2026
• Initial Report FDA Received Date: 06/09/2026
• Supplement Report FDA Received Date: 06/09/2026; 06/29/2026
• 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
• Patient Sex: Unknown