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

Model Number	33310ML
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bowel Burn (1756)
Date of Event	02/12/2026
Type of Reportable Event	Serious Injury
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).
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: 9610617-2026-00499; 9610617-2026-00500.
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Investigation: all returned items were carefully inspected, and no damage was identified on any of them beyond normal wear and tear.Based on the customer's description, an electrical current was allegedly detected in the upper section near the handle.However, the handle is made entirely of plastic, which makes it impossible for electrical current to pass through it.The only plausible explanation would be damage to the insulation of the shaft, allowing current to leak and potentially cause a burn.Unfortunately, we do not have any images, information on the age, or the exact model number of the outer shaft.Despite multiple follow-up requests, no additional details could be obtained.No corrective actions necessary as there is no critical and/or systematic deviation found during investigation.The event is filed under internal karl storz 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: 24553363
• Report Number: 9610617-2026-00501
• Device Sequence Number: 12156003
• Product Code: GCJ
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K935071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/17/2026

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: 33310ML
• Device Catalogue Number: 33310ML
• Device Lot Number: VK45
• 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: 02/13/2026
• Supplement Date Received by Manufacturer: 03/18/2026; 05/27/2026; 06/17/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 03/25/2026; 06/08/2026; 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Required Intervention
• Patient Sex: Unknown