MAUDE Adverse Event Report: KARL STORZ SE & CO. KG COAGULATING AND DISSECTING ELECTRODE

Model Number	26775UF
Medical Device Problem Codes	Material Fragmentation (1261); Overheating of Device (1437); Use of Device Problem (1670)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/29/2024
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.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that patient underwent a laparoscopic hysterectomy bilateral salpingo oophorectomy with bowel adhesiolysis.Lap hook was used intra-operatively and tip of the hook was found broken on the laparoscopic tv screen while using by the surgical team.A thorough search was performed but to no avail as the tip that was chipped off was too small.Intra-operative x-rays were ordered to locate for the missing hook tip.Tip was finally found at the end of the surgery through x-ray in the specimen pieces.This incident resulted in the patient undergoing longer than usual general anaesthesia and additional x-ray screenings.
Additional Manufacturer Narrative
The device in question was returned to the manufacturer on november 21/2024.This information is reflected in section d9.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.Additional information received on d4 lot#: rr01 the event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Result of investigation: the investigation shows that the device exhibits severe wear at the distal end, and a part if the tip is missing.A probable reason for this could be that the electrode was operated for too long or at too high a voltage.The instructions for use clearly state that the device is suitable for a recurring peak voltage of max.3.0 kvp and only for short-term coagulation.Since the device was already more than six years old at the time of the incident, it is also possible that it showed signs of wear due to the likely applications during the service life of the device.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: COAGULATING AND DISSECTING ELECTRODE
• Common Device Name: COAGULATING AND DISSECTING ELECTRODE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr,-kark - storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr,-kark - storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 20635613
• Report Number: 9610617-2024-00441
• Device Sequence Number: 7506822
• Product Code: GEI
• UDI-Device Identifier: 04048551072417
• UDI-Public: 04048551072417
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K944796
• 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,Followup
• Report Date (Section B): 12/04/2024

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: 26775UF
• Device Catalogue Number: 26775UF
• Device Lot Number: RR01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2024
• Supplement Date Received by Manufacturer: 11/21/2024; 12/03/2024
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 11/25/2024; 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Required Intervention
• Patient Sex: Unknown