MAUDE Adverse Event Report: KARL STORZ SE & CO. KG KOH ASSISTANT NEEDLEHOLDER

Model Number	26173KG
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2024
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
According to the information received, a spontaneous breakage of the instrument occurred during its first use, when the needle was being taken.In particular, the breakage of the instrument occurred spontaneously and not due to the operator during the packing of the purse-string suture of the service of an intracorporeal ileocolic mechanical anastomosis; therefore, during a procedure that does not require particular stress of the instrument and involves the use of very fine needles.
Additional Manufacturer Narrative
Additional information: the device in question was not returned to the manufacturer.Therefore, a detailed visual and functional inspection of the actual damage was not possible, and the exact failure mechanism cannot be conclusively confirmed.All production and quality-control records were reviewed.A review of the labelling and instructions for use confirmed that adequate warnings, precautions, and instructions regarding correct needle selection, intended use, and force application are provided.A review of global complaint data for this product family did not reveal similar cases of jaw breakage.No trend, signal, or systemic issue was identified.Based on the available information and similar known failure mechanisms, the most probable root cause is excessive mechanical load applied during use, potentially associated with incorrect needle size or improper handling.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: KOH ASSISTANT NEEDLEHOLDER
• Common Device Name: KOH ASSISTANT NEEDLEHOLDER
• 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: 21861772
• Report Number: 9610617-2025-00648
• Device Sequence Number: 4721124
• Product Code: GCJ
• UDI-Device Identifier: 04048551098196
• UDI-Public: 04048551098196
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2025

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: 26173KG
• Device Catalogue Number: 26173KG
• Device Lot Number: XM02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 12/22/2025
• 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