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

Model Number	33410ON
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	02/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the atraumatic grasper created a tear/hole on the stomach, and it was not being pulled on.The surgeon said that she would have needed to suture the holes, had that part of the stomach remained inside the patient.Fortunately, it was the part of the stomach that was removed from the body.The surgeon mentioned that it happened in another case a week or two ago.Cross reference mdr 9610617-2025-00241.
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.Cross reference complaint id: (b)(4).This event is filed under internal complaint id (b)(4).

• Brand Name: CLICKLINE FORCEPS INSERT
• Common Device Name: CLICKLINE FORCEPS INSERT
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 21393856
• Report Number: 2020550-2025-00242
• Device Sequence Number: 8595285
• Product Code: GCJ
• UDI-Device Identifier: 04048551143285
• UDI-Public: 04048551143285
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 02/17/2025
• Report Date (Section F): 02/17/2025

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: 33410ON
• Device Catalogue Number: 33410ON
• Device Lot Number: OP08
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/06/2025
• Event Location: Hospital
• Date Report to Manufacturer: 02/17/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/18/2025
• 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