MAUDE Adverse Event Report: TELEFLEX MEDICAL DISP. IMA/ENT 3/4 NEEDLE ELECTRODE; ELECTROCAUTERY, GYNECOLOGIC

Catalog Number	809337
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	08/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the "bovie tip had a hole in the insulation, and caused a burn to the patient's skin.Bovie tip removed from field and replaced.Wound debrided and covered with petrolatum jelly".The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The complaint sample was not returned.Aspen surgical, the manufacturing site reported: "product was purchased on an unknown order number from symmetry surgical to teleflex.Customer was using bovie/teleflex needle electrode 809337 with unknown lot number with coviden pencil e2515h.Customer stated the electrode was inserted into medtronic/coviden handpiece; however, electrode shaft had exposed metal when inserted.Customer stated handpiece had more room to accept more length of the shaft of the electrode, but it was not noticed until after the injury occurred that the electrode should have been pushed in further.Complaint confirmed through conversation with customer.Medtronic has this logged this complaint in their system.Review of product details of coviden handpiece part number e2515h was able to be completed by medtronic team to confirm that the electrode used in this procedure is compatible with the handpiece used in this procedure.Reference attached email "confirmation of root cause from medtronic - user error.Root cause was that the product electrode was not fully inserted into the handpiece by the end user.The exposed shaft of the electrode allowed by the end user let the electricity flow through the stem of the electrode into the patient rather than through the return electrode.Device is not able to be returned.Pictures of the device were not able to be received.Pictures of the burn site were not able to be received." teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that the "bovie tip had a hole in the insulation, and caused a burn to the patient's skin.Bovie tip removed from field and replaced.Wound debrided and covered with petrolatum jelly".The patient status is reported as "fine".

• Brand Name: DISP. IMA/ENT 3/4 NEEDLE ELECTRODE
• Common Device Name: ELECTROCAUTERY, GYNECOLOGIC
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17700685
• Report Number: 3011137372-2023-00217
• Device Sequence Number: 6631972
• Product Code: HGI
• UDI-Device Identifier: 14026704736086
• UDI-Public: 14026704736086
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K942986
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2023

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 Expiration Date: 05/01/2025
• Device Catalogue Number: 809337
• Device Lot Number: 0521K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2023
• Supplement Date Received by Manufacturer: 09/29/2023
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 10/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown