MAUDE Adverse Event Report: KARL STORZ SE & CO. KG MONOPOLAR DISSECTING L-SHAPED ELECTRODE, 5MM X 36CM; COAGULATING AND DISSECTING ELECTRODE

Model Number	26775UF
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was discarded, therefore no physical investigation is possible.By reviewing the similar incident and complaint, the root cause could potentially be due to exerting too much force during use.The device was manufactured in 2012.
Event or Problem Description
As per a manufacturer incident report we received from the factory in (b)(6): as reported: during a laparoscopic appendicectomy a diathermy tip (26775uf) broke away whilst inside the patient.The incident happened on thursday (15/04).The consultant took the following steps to find the missing tip but was unsuccessful.As it stands the location of the tip is still unknown.Checked pelvic area, checked ports and drapes, checked floor, x - ray was called to theatres however the tip wasn't found, wash out of the abdomen.After the procedure the patient was informed of the incident.Remaining part of device disposed of in sharps bin".

• Brand Name: MONOPOLAR DISSECTING L-SHAPED ELECTRODE, 5MM X 36CM
• Common Device Name: COAGULATING AND DISSECTING ELECTRODE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• MDR Report Key: 11895906
• Report Number: 9610617-2021-00048
• Device Sequence Number: 17071226
• Product Code: GEI
• UDI-Device Identifier: 04048551072417
• UDI-Public: 4048551072417
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 26775UF
• Device Catalogue Number: 26775UF
• Device Lot Number: PX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2021
• Initial Report FDA Received Date: 05/27/2021
• 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