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
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).
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: 9610617-2025-01486.9610617-2025-01498.9610617-2025-01499.

• 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: 22919587
• Report Number: 2020550-2025-01497
• Device Sequence Number: 18699798
• 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