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

Model Number	33300
Medical Device Problem Codes	Crack (1135); 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.

• 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
• MDR Report Key: 22955871
• Report Number: 2020550-2025-01532
• Device Sequence Number: 9894137
• Product Code: GCJ
• UDI-Device Identifier: 04048551002308
• UDI-Public: 04048551002308
• 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,Followup
• Report Date (Section B): 10/08/2025
• Report Date (Section F): 10/07/2025

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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/18/2025
• Event Location: Hospital
• Date Report to Manufacturer: 10/07/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 10/08/2025
• 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