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

Model Number	33121
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); 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 20192-104 from (b)(6).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: 9610617-2025-01486.9610617-2025-01497.9610617-2025-01498.
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).

• 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: 22919589
• Report Number: 2020550-2025-01499
• Device Sequence Number: 10231128
• Product Code: GCJ
• UDI-Device Identifier: 04048551001097
• UDI-Public: 04048551001097
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 08/28/2025
• Report Date (Section F): 08/28/2025

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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/14/2025
• Event Location: Hospital
• Date Report to Manufacturer: 08/28/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/28/2025
• 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: Other
• Patient Sex: Unknown