MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CLICKLINE PLASTIC HANDLE

Model Number	33151
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bowel Burn (1756)
Date of Event	02/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during laparoscopic surgery for the treatment of endometriosis, a unipolar high frequency cord was attached to the handle for use with a maryland grasper.The metal jaws were applied to tissue deep within the utero pelvic region, and the surgeons ensured that no surrounding structures were involved before applying coagulation.Cross reference mdr: 9610617-2026-00500; 9610617-2026-00501.
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: CLICKLINE PLASTIC HANDLE
• Common Device Name: CLICKLINE PLASTIC HANDLE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 24553317
• Report Number: 2020550-2026-00499
• Device Sequence Number: 9386368
• Product Code: GCJ
• UDI-Device Identifier: 04048551009369
• UDI-Public: 04048551009369
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 03/09/2026
• Report Date (Section F): 03/09/2026

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: 33151
• Device Catalogue Number: 33151
• Device Lot Number: TK01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/13/2026
• Event Location: Hospital
• Date Report to Manufacturer: 03/09/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/09/2026
• 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 Sex: Unknown