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

Model Number	33310K
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Liver Laceration(s) (1955)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will be forwarded to the manufacturer for further investigation.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 has been reported the surgeon had a situation where the cul-de-sac had a significant amount of blood in it and blindly grasped the bowel instead of the cyst they intended to retrieve.The surgeon was speculative that the sharp edge could have cut the serosa.Since the patient got injured, the case is deemed as reportable.

• 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: 23879087
• Report Number: 2020550-2025-02421
• Device Sequence Number: 9605153
• 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): 12/23/2025

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
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/23/2025
• 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
• Patient Sex: Unknown