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

Model Number	26775UF
Medical Device Problem Code	Material Fragmentation (1261)
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.

• 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
• MDR Report Key: 20636570
• Report Number: 2020550-2024-00441
• Device Sequence Number: 18014513
• Product Code: GEI
• UDI-Device Identifier: 04048551072417
• UDI-Public: 04048551072417
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 11/07/2024
• Report Date (Section F): 11/07/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/01/2024
• Event Location: Hospital
• Date Report to Manufacturer: 11/07/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/07/2024
• 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: Required Intervention
• Patient Sex: Unknown