MAUDE Adverse Event Report: KARL STORZ SE & CO. KG FASCIAL CLOSURE INSTRUMENT, 2.8MM, 17CM

Model Number	26173AM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a case the tip of the device broke off into the patient.The incision was enlarged to search for and remove the broken piece from patient's abdominal tissue.Patient was under a prolong anesthesia due to additional removing broken piece procedure and x-rays confirmation as the end of the procedure.The tip was discarded as it was removed from inside the patient.The procedure was prolonged by 45 to 60 minutes.
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).

• Brand Name: FASCIAL CLOSURE INSTRUMENT, 2.8MM, 17CM
• Common Device Name: FASCIAL CLOSURE INSTRUMENT, 2.8MM, 17CM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78532 ,; GM 78532,
• MDR Report Key: 21921838
• Report Number: 2020550-2025-00708
• Device Sequence Number: 8714547
• Product Code: GCJ
• UDI-Device Identifier: 04048551097755
• UDI-Public: 04048551097755
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 04/28/2025
• Report Date (Section F): 04/28/2025

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: 26173AM
• Device Catalogue Number: 26173AM
• Device Lot Number: UN04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/10/2025
• Event Location: Hospital
• Date Report to Manufacturer: 04/28/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/28/2025
• 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: Other; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 73 KG