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

Model Number	34310MA-D
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not returned at the time of mdr submission.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
According to the information available, the insulation on the shaft of the disposable scissors was charred during surgery.No negative effects on the procedure, the patient, the user, or third parties have been reported.No death or (unanticipated) serious deterioration in state of health reported.
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.This information is reflected in section d9.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
Result of investigation: examination of item 34310ma-d reveals several mechanical damages to the insulation, in particular abrasion marks and a torn piece at the distal end.These damages indicate improper handling during use, presumably by pulling the instrument out of a shaft with sharp edges.Safety and handling instructions emphasize the importance of careful inspection and proper use of medical instruments.The following points are particularly relevant: excessive force is expressly prohibited as it may result in breakage or malfunction (see warning notice regarding overload).Instruments must be checked for damage before and after each use, especially for sharp edges, protruding parts, or other irregularities.Combination with hf devices requires intact insulation to ensure patient safety.The damage observed clearly contradicts these specifications.It is therefore very likely that the damage to the insulation was not caused by a material defect, but by incorrect use or improper handling.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: CLICKLINE SCISSORS INSERT
• Common Device Name: CLICKLINE SCISSORS 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: 22185967
• Report Number: 9610617-2025-00972
• Device Sequence Number: 8401955
• Product Code: GEI
• UDI-Device Identifier: 04048551336434
• UDI-Public: 04048551336434
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K151044
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 34310MA-D
• Device Catalogue Number: 34310MA-D
• Device Lot Number: UL03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2025
• Supplement Date Received by Manufacturer: 06/23/2025; 08/28/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 07/08/2025; 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Sex: Unknown