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

Model Number	33121
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Arcing (2583); Device Damaged by Another Device (2915); Excessive Heating (4030)
Health Effect - Clinical Code	Burn(s) (1757)
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported: during surgery, the physician got a slight burn on the hand while using our clickline instruments in conjunction with monopolar current.The customer uses our handle 33121 in combination with the monopolar cable (b)(6) from erbe medizintechnik.When the cable is plugged in, it does not close tightly, leaving a small gap.The injury occurred during spray coagulation, which requires a relatively high voltage.Cross reference mdr: 9610617-2025-01486.9610617-2025-01497.9610617-2025-01499.
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.Cross reference complaint id: (b)(4).The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Since the affected item was not sent in for inspection, this reinvestigation was done based on two sources of information: information provided by the customer and research report by the product specialist service.The analysis shows that the risk of electrical breakdowns and burns was significantly increased by the specific application situation.The user used an unsuitable connection cable (erbe 20192-104), which meant that the hf connection of the 33121 handle was not completely insulated.In addition, the maximum technically permissible peak voltage of 3.0 kvp was significantly exceeded.Another decisive factor was that the index finger was positioned directly below the uninsulated connection, which further increased the risk of an electrical breakdown.The incident could most likely have been avoided if the user had used the correct connection cable (e.G., karl storz 26005m) and adhered to the recommended voltage settings.The improper selection of components and the positioning of the finger thus contributed significantly to the damage.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
• Manufacturer (Section G): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 22919590
• Report Number: 9610617-2025-01498
• Device Sequence Number: 10231129
• Product Code: GCJ
• UDI-Device Identifier: 04048551001097
• UDI-Public: 04048551001097
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K935071
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2025

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: 33121
• Device Catalogue Number: 33121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2025
• Supplement Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 10/16/2025
• 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