MAUDE Adverse Event Report: KARL STORZ SE & CO. KG SUTURE PASSER

Model Number	50173AM
Medical Device Problem Code	Break (1069)
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.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id (b)(4).
Event or Problem Description
It was reported that the customer was using a suture passer instrument during a laparoscopic appendectomy and the tip broke inside the tissue of the abdominal wall.The tip was removed from the patient using c-arm guidance.

• Brand Name: SUTURE PASSER
• Common Device Name: SUTURE PASSER
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78532 ,; GM 78532,
• MDR Report Key: 24317430
• Report Number: 2020550-2026-00273
• Device Sequence Number: 5572486
• Product Code: MDM
• UDI-Device Identifier: 04048551170076
• UDI-Public: 04048551170076
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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): 02/11/2026
• Report Date (Section F): 02/11/2026

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: 50173AM
• Device Catalogue Number: 50173AM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/22/2026
• Date Report to Manufacturer: 02/11/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/11/2026
• 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