MAUDE Adverse Event Report: KARL STORZ SE & CO. KG FORCEPS ATTACHMENT

Model Number	26168JC
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2025
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 during a surgery the screw of the device insert was lost and the doctor was able to remove it from situ accordingly.No negative impact in state of health reported.
Additional Manufacturer Narrative
The device in question was returned to manufacturer.This information is reflected in section d9.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.Concomitant medical products added in section d10: article: 26168jq manipulator sheath, lot number: yp01, product was returned on february 19, 2026.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
The investigation shows that the loss of the rivet is most likely due to pre-existing damage to the welded joint.This may have been exacerbated by excessive mechanical stress and/or moisture-induced corrosion processes, possibly as a result of improper preparation or insufficient drying.Compliance with the reprocessing instructions and instruction for use, particularly the pre-use inspection, is therefore crucial for detecting such damage early and preventing future incidents.Appropriate warnings about the visual inspection before use and a functional check are included in the corresponding instruction for use.This instructions need to be observed to avoid any injury or risk to patient user or third.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Correction provided in section h6.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: FORCEPS ATTACHMENT
• Common Device Name: FORCEPS ATTACHMENT
• 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: 24206547
• Report Number: 9610617-2026-00083
• Device Sequence Number: 9855568
• Product Code: HIH
• UDI-Device Identifier: 04048551258002
• UDI-Public: 04048551258002
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K992027
• 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,Followup
• Report Date (Section B): 05/04/2026

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: 26168JC
• Device Catalogue Number: 26168JC
• Device Lot Number: UL01
• 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: 12/29/2025
• Supplement Date Received by Manufacturer: 02/11/2026; 04/27/2026; 05/04/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 03/11/2026; 04/29/2026; 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 26168JQ: - MANIPULATOR SHEATH.LOT: YP01.
• Patient Sex: Unknown