MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ULTRAMICRO NEEDLE HOLDER, SIZE 3 MM

Model Number	26167FNS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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 a needle holder broke during surgery.No negative impact in state of health reported.
Additional Manufacturer Narrative
Additional information is provided in section d4 and d9.Internal karl storz reference number: (b)(4).

• Brand Name: ULTRAMICRO NEEDLE HOLDER, SIZE 3 MM
• Common Device Name: ULTRAMICRO NEEDLE HOLDER, SIZE 3 MM
• 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: 23606877
• Report Number: 9610617-2025-02099
• Device Sequence Number: 18456244
• Product Code: GCJ
• UDI-Device Identifier: 04048551095362
• UDI-Public: 04048551095362
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K951625
• 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
• Report Date (Section B): 02/12/2026

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: 26167FNS
• Device Catalogue Number: 26167FNS
• Device Lot Number: GA05
• 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: 11/11/2025
• Supplement Date Received by Manufacturer: 01/19/2026
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 02/12/2026
• 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