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

Model Number	33410ON
Medical Device Problem Codes	Break (1069); Insufficient Device Problem Information (3190); Appropriate Device Problem Term/Code Not Available (3191); Sharp Edges (4013)
Health Effect - Clinical Codes	Perforation (2001); Insufficient Information (4580)
Date of Event	02/05/2025
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.Cross reference complaint id: (b)(4).This event is filed under internal complaint id (b)(4).
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
Per investigation findings by the manufacturing site: during the analysis of the similar case it was found that the pull rod was significantly bent in the upper and lower areas.As the pull rod must be straight due to its design, this deformation is considered atypical.Due to the material properties and mechanical stability of the component, it can be assumed that the bending was caused by excessive force during use.Such deformation is not to be expected under normal conditions of use.Based on the results of the investigation, the documented product quality, and the previous complaint history, no product-related defect can be identified.The cause of the reported injury cannot therefore be attributed to a defect in the item.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
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 21398760
• Report Number: 9610617-2025-00242
• Device Sequence Number: 7746955
• Product Code: GCJ
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K935071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2026

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2025
• Supplement Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown