MAUDE Adverse Event Report: KARL STORZ SE & CO. KG MACRO NEEDLE HOLDER, 5 MM, 33 CM; SUTURING NEEDLE HOLDER, REUSABLE

Model Number	26173KL
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	01/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, tungsten plaque found during a laparoscopy in the patients abdomen.Removed and set aside.No death or unanticipated serious deterioration in state of health 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: the tungsten fragment found in the patient's abdomen during surgery indicates the detachment of a brazed carbide plate from a surgical instrument, presumably a needle holder.The cause cannot be conclusively determined without product analysis, but a combination of material fatigue, thermal stress from repeated sterilization, and possible mechanical overload during use is likely.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: MACRO NEEDLE HOLDER, 5 MM, 33 CM
• Common Device Name: SUTURING NEEDLE HOLDER, REUSABLE
• 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: 21318173
• Report Number: 9610617-2025-00127
• Device Sequence Number: 8129015
• Product Code: GCJ
• UDI-Device Identifier: 04048551001110
• UDI-Public: 04048551001110
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 10/13/2025

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: 26173KL
• Device Catalogue Number: 26173KL
• Device Lot Number: VP09
• 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: 01/21/2025
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 10/15/2025
• 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