MAUDE Adverse Event Report: KARL STORZ SE & CO. KG FORCEPS INSERT

Model Number	33310K
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Gastrointestinal Hemorrhage (4476)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the surgeon had a situation where the grasper got stuck in the omentum and it took some gentle dissection to get it out.The sharp corner where the grasper is connects to the shaft is what was stuck.The surgeon had a situation where the grasper got stuck in the omentum and it took some gentle dissection to get it out.The sharp corner where the grasper is connects to the shaft is what was stuck.Small epiploica serosal injury as it was snagged on the epiploica - however, if this happened on the bowel serosa, it could cause a perforation/tear of the bowel, expectantly managed.Due to the small epiploica.
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); complaint (b)(4).

• Brand Name: FORCEPS INSERT
• Common Device Name: FORCEPS INSERT
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78523 2; GM 785232
• MDR Report Key: 21778479
• Report Number: 2020550-2025-00561
• Device Sequence Number: 7867848
• Product Code: GCJ
• UDI-Device Identifier: 04048551134290
• UDI-Public: 04048551134290
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 04/04/2025
• Report Date (Section F): 04/04/2025

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: 33310K
• Device Catalogue Number: 33310K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/25/2025
• Event Location: Hospital
• Date Report to Manufacturer: 04/04/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2025
• 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: Required Intervention
• Patient Age: 31 YR
• Patient Sex: Unknown
• Patient Weight: 74 KG