MAUDE Adverse Event Report: KARL STORZ SE & CO. KG COAGULATING ELECTRODE, 6 FR.; ENDOSCOPIC ELECTROSURGICAL ELECTRODE

Model Number	27770C
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that during procedure, tip noticed missing upon withdrawal.Unable to find tip.Surgeon assessed risk to patient as very low even if it was still in the bladder.No negative impact in state of health reported.
Additional Manufacturer Narrative
The product was returned on 2024-11-15.The investigation of the product was completed on 2024-12-11.During the technical investigation of the returned product, the following was found:: the electrode tip has become detached on the distal side.As the article was already produced in 2017 and a corresponding number of reprocessings can be assumed, this is wear and tear.It must be assumed that the user is at fault.According to the ifu electrodes need to be checked before each use.If there are any signs of damage they must not be used in any circumstances.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: COAGULATING ELECTRODE, 6 FR.
• Common Device Name: ENDOSCOPIC ELECTROSURGICAL ELECTRODE
• 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: 20820479
• Report Number: 9610617-2024-00464
• Device Sequence Number: 7636988
• Product Code: FAS
• UDI-Device Identifier: 04048551089965
• UDI-Public: 04048551089965
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K944795
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2024

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: 27770C
• Device Catalogue Number: 27770C
• Device Lot Number: OS01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 12/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2017
• 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