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

Model Number	26176HT
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Correct information was received on march 2, 2026.The initial product information (article-no.66176ha; vet product) received from the customer was not correct.The correct article-no.Is 26176ht.The product concerned (26176ht) is also intended for use during human medical procedures.Apart from this, the information regarding this case did not change.Therefore, the reporting decision remains the same and the case is still deemed reportable as a malfunction.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that "the forceps have stopped working.The insert looks to have been pulled away from the handle and now a wire is disconnected (she thinks someone may not have pushed the button to release the insert).Unfortunately, did not have a spare and already cauterized the ovary, will need to convert to an open procedure".No negative impact on the state of health for a human is reported.
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).
Additional Manufacturer Narrative
Additional information is provided in section d9 to reflect that the product was returned for evaluation.The investigation is not completed yet.The investigation results are pending.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 ; GM 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: 24267551
• Report Number: 9610617-2026-00222
• Device Sequence Number: 10669331
• 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): 03/31/2026

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
• 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: 01/23/2026
• Supplement Date Received by Manufacturer: 03/02/2026; 03/09/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 03/03/2026; 03/31/2026
• 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
• Patient Sex: Unknown