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

Model Number	IPN029475
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4) n/a.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that prior to use in the clinical setting, "after 2 electrodes melted" an additional electrode from a new package was used and it "emitted a flame".No patient involvement.
Additional Manufacturer Narrative
Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.Other remarks: n/a corrected data: n/a.
Event or Problem Description
It was reported that prior to use in the clinical setting, "after 2 electrodes melted" an additional electrode from a new package was used and it "emitted a flame".No patient involvement.Additional information received on 16 may 2023 states that a 4th electrode was used to complete the procedure."the first tip was used for about 30 seconds and it began to melt.The second tip was used for just a few seconds and began to melt.The third tip (fire) lit immediately upon activation." the 4th electrode was from a different lot number than the ones that issues occurred with.The procedure being performed was a vaginal posterior repair, there was no tissue or eschar buildup on the electrode as the electrode was use at the beginning of the procedure, there was no facial/body hair.Normal anesthetic gasses were used for general anesthesia.The customer was unsure what voltage was being used when the issue occurred.Associated mdrs: 3011137372-2023-00128, 3011137372-2023-00130.

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16923878
• Report Number: 3011137372-2023-00131
• Device Sequence Number: 6805331
• Product Code: HGI
• UDI-Device Identifier: 14026704646026
• UDI-Public: 14026704646026
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 04/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2025
• Device Model Number: IPN029475
• Device Catalogue Number: 809337
• Device Lot Number: 0421A
• 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: 04/21/2023
• Supplement Date Received by Manufacturer: 07/10/2023
• Initial Report FDA Received Date: 05/12/2023
• Supplement Report FDA Received Date: 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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