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

Model Number	26173KAL
Medical Device Problem Codes	Crack (1135); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.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 that after completing the surgery on the patient, the surgeon noticed that the tip of the needle holder was broken.After the surgery, an x-ray examination confirmed that the damaged fragment remained.It will be collected.The broken tip remained in patient and a further surgery to recover the piece is likely.
Additional Manufacturer Narrative
The product was not available at kst but could be investigated directly in japan.The following was found: based on the inspection of item 26173kal, it was found that the movable jaw part, which serves as the pivot point for opening and closing the needle holder tip, was damaged.It was also confirmed that there were several traces of damage on the surface other than the gripping surface of the tip lock.The needle was not only clamped on the surface of the gripping surface, but also behind the carbide surface.When the needle is clamped on this surface, the upper and lower clamping surfaces are enlarged, which leads to a load on the pull rod due to leverage forces and thus to damage to the pull rod.The ifu warns against applying excessive force.It is also described in the reprocessing instructions that the article must be checked for damage before each use.Furthermore, the device history records have been checked and found to be according to the specification, valid at the time of production.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
• 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: 17837265
• Report Number: 9610617-2023-00271
• Device Sequence Number: 17994430
• Product Code: GCJ
• UDI-Device Identifier: 04048551098127
• UDI-Public: 4048551098127
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K951060
• 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
• Report Date (Section B): 12/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 26173KAL
• Device Catalogue Number: 26173KAL
• Device Lot Number: W06
• 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: 09/12/2023
• Supplement Date Received by Manufacturer: 12/13/2023
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 12/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown