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

Model Number	26173KAL
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information is provided in section d9, to reflect that the product was returned for evaluation.The investigation is not completed yet.The investigation results are pending.Correction in section d4, is to provide the correct lot number.The event is filed under internal karl storz complaint id: (b)(4).
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 the doctor stitched the incision after the hysteromyectomy of the patient.After stitching only 1-2 stitches, the doctor heard a "snap" sound of the needle holder.After removing the needle holder, the nurse found that there were small pieces of the needle holder missing.The instrument nurse shook the needle holder and found two small fragments.The doctor used a magnet to suck the surface of the abdominal organs and did not suck out missing parts.The hospital contact the manufacturer to report that the main missing two pieces are found, but there may have debris remain.Intraoperative c-arm fluoroscopy was performed with two different modes and no residual was found.The director of the report and the superior deputy consultant considered that the possibility of pieces remaining in the body was small, and no harm was caused to patients.
Additional Manufacturer Narrative
Device evaluation: during the inspection of the macro needle holder, it was found that the movable jaw part, which serves as the pivot point for opening and closing the needle holder tip, was damaged.Based on the damage found, a probable scenario could be that the needle was not clamped on the surface of the gripping surface, but 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.In addition, slight traces of corrosion can be seen, which may have facilitated the breakage.The corresponding ifu of the product warns against applying excessive force.The reprocessing instructions also state that the item must be checked for damage and corrosion.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: 19315835
• Report Number: 9610617-2024-00135
• Device Sequence Number: 15181181
• Product Code: GCJ
• UDI-Device Identifier: 04048551098127
• UDI-Public: 04048551098127
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 09/10/2024

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: RN08
• 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: 04/29/2024
• Supplement Date Received by Manufacturer: 07/30/2024; 09/09/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 08/02/2024; 09/10/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown