MAUDE Adverse Event Report: KARL STORZ SE & CO. KG METAL OUTER SHEATH, INSULATED, 36 CM

Model Number	33300
Medical Device Problem Codes	Crack (1135); Material Fragmentation (1261); Excessive Heating (4030)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	08/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery; the patient suffered a minor burn.A tapp was performed on the right side.A defective outer shaft was used during the operation.The insulation was damaged.The defective insulation caused electricity to be conducted to the trocar, resulting in the burn.The insulation of the outer shaft was damaged.No negative impact in state of health reported.
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).
Additional Manufacturer Narrative
The defective items will not be returned to the manufacturer.As the hospital does not have its own central sterile supply department, the instruments are reprocessed by an external service provider, medical order in ahlen.This company replaced and disposed of the defective instruments on the tray, meaning that they are unfortunately not available for examination.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
According to the additional information received the patient suffered a minor burn during the surgery.A tapp was performed on the right side.A defective outer shaft was used during the operation.The insulation was damaged.The defective insulation caused the current to be conducted to the trocar, resulting in the burn.The surgery was completed successfully and no additional medical interventionw as required.All in all there are no adverse consequences for the patient.
Additional Manufacturer Narrative
Additional information: the complaint product was not available for investigation.The complaint sample has been requested at least 3 times.According to the reprocessing unit of the customer the complaint sample has been discarded.Therefore, a final determination of the root cause is not possible.Taking into account the injury of the patient, the statement of the nurses and our experience with similar errors, it is most likely that the insulation of the metal sheath of the clickline instrument has been damaged and hf current has flown over the trocar into the patient causing the mild burn.The device quality and manufacturing history records have been checked for the available information and were found to be according to our specifications valid at the time of production.The instrction for use contains adequate instructions and warnings to insepct the device before each use to avoid any patient hazard.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: METAL OUTER SHEATH, INSULATED, 36 CM
• Common Device Name: METAL OUTER SHEATH, INSULATED, 36 CM
• 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: 22955872
• Report Number: 9610617-2025-01532
• Device Sequence Number: 15926342
• Product Code: GCJ
• UDI-Device Identifier: 04048551002308
• UDI-Public: 04048551002308
• 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,Followup
• Report Date (Section B): 10/28/2025

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: 33300
• Device Catalogue Number: 33300
• 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: 08/18/2025
• Supplement Date Received by Manufacturer: 09/09/2025; 10/21/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 10/07/2025; 10/28/2025
• 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