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

Model Number	IPN029475
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#: (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
Second degree burn oral commissure.Insulated bovie electrode needle inserted into bovie covidien pencil, despite incomplete insertion of the bounce electrode in the bovie pencil a complete circuit existed.Limited topical treatment.
Additional Manufacturer Narrative
Qn# (b)(4).A visual inspection of the product involved in the complaint could not be conducted since the product was not returned.A dimensional inspection was not required as part of this investigation.A functional inspection was not required as part of this investigation.No failure mode identified.The device is a simple disposable electrode.The complaint description also details additional devices including a bovie pencil and a switch which connects to and provides current to the electrode.
Event or Problem Description
Second degree burn oral commissure.Insulated bovie electrode needle inserted into bovie covidien pencil, despite incomplete insertion of the bounce electrode in the bovie pencil a complete circuit existed.Limited topical treatment.

• Brand Name: DISP. IMA/ENT 3/4 NEEDLE ELECTRODE
• Common Device Name: ELECTROCAUTERY, GYNECOLOGIC
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11633201
• Report Number: 3011137372-2021-00078
• Device Sequence Number: 19682264
• Product Code: HGI
• UDI-Device Identifier: 14026704646026
• UDI-Public: 14026704646026
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2021

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: IPN029475
• Device Catalogue Number: 809337
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/18/2021
• Supplement Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 04/08/2021
• Supplement Report FDA Received Date: 05/14/2021
• 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: Required Intervention