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
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.

• 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
• MDR Report Key: 19315836
• Report Number: 2020550-2024-00135
• Device Sequence Number: 6911315
• Product Code: GCJ
• UDI-Device Identifier: 04048551098127
• UDI-Public: 4048551098127
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/14/2024
• Report Date (Section F): 05/14/2024

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: RN07
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/13/2024
• Event Location: Hospital
• Date Report to Manufacturer: 05/14/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/14/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown