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

Model Number	26173KPL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.Internal karl storz reference number: (b)(4).
Event or Problem Description
It was reported that the product had "broken jaws." there is no information that the event caused a harm or serious injury to patient, user or third.
Additional Manufacturer Narrative
It was stated that "jaw didn't close right" and it was furthermore indicated that the defect was mentioned by the or department, but it is unknown if it happened before, during or after surgery.No negative impact in state of health reported.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Result of investigation: it was determined that there was an error in the assembly of the needle holder.The preload on the handle was too high.According to the manufacturer, the head of the steel assembly department checked the needle holders for defects.At the same time, he inspected the work of the assembly employees.Incorrect assembly.Excessive pretension on the handle.The excessive pretension on the handle results from faulty assembly.When installing the pull-up attachment, in which the pull rod is installed, an incorrect setting was made.The pull rod was screwed too far into the handle, creating increased pressure.If the jaw is repeatedly opened and loosed, the pressure increases progressively, eventually causing the pull rod to break.A production fault can be confirmed.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: MACRO NEEDLE HOLDER, 5 MM, 33 CM
• Common Device Name: MACRO NEEDLE HOLDER, 5 MM, 33 CM
• 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: 21471623
• Report Number: 9610617-2025-00324
• Device Sequence Number: 18307372
• Product Code: GCJ
• UDI-Device Identifier: 04048551098233
• UDI-Public: 04048551098233
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/17/2025

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: 26173KPL
• Device Catalogue Number: 26173KPL
• Device Lot Number: YM01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2025
• Supplement Date Received by Manufacturer: 03/03/2025; 06/16/2025
• Initial Report FDA Received Date: 02/26/2025
• Supplement Report FDA Received Date: 03/12/2025; 06/17/2025
• 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
• Patient Sex: Unknown