MAUDE Adverse Event Report: TELEFLEX MEDICAL WECK DISPOSABLE IMA/ENT 3/4; ELECTROCAUTERY, GYNECOLOGIC

Catalog Number	809337
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#: (b)(4).Udi#: (b)(4).Medwatch report number: (b)(4).
Event or Problem Description
It was reported via medwatch, "it was reported that "during the procedure, the teleflex needle electrode tip was noted to have a large spark, the setting was at 60, the staff lowered to 40; it still had a spark.Teleflex tip then switched out with no resolution.The bovie pencil, bovie tip and bovie machine was changed out and megadyne pad not used.A bovie pad placed; however, the surgeons did not need to bovie anymore, so not sure if that resolved the issue".The patient's current condition is reported as "n/a.Bovie spark did not impact the patient's condition".Additional information also states that there were no health consequences to the patient and no medical intervention required.
Additional Manufacturer Narrative
(b)(4).A visual inspection of the product involved in the complaint could not be conducted since the product was not returned.Reviews were conducted pertaining to incoming inspection, stock checks, and product returns.No concerns were noted with reference to bovie electrodes.The device is a monopolar electrode which conducts energy from a bovie pencil to the patient.Energy should only be activated while the electrode is in contact with the target tissue.In order for a spark to occur the electrode was energized when an air gap existed between the two poles.Arcing occurs in air when the voltage potential exceeds 30 ,000 volts per centimeter.The fact that arcing was observed at the electrode tip indicates that the device was working correctly.
Event or Problem Description
It was reported via medwatch "it was reported that "during the procedure, the teleflex needle electrode tip was noted to have a large spark, the setting was at 60, the staff lowered to 40; it still had a spark.Teleflex tip then switched out with no resolution.The bovie pencil, bovie tip and bovie machine was changed out and megadyne pad not used.A bovie pad placed; however, the surgeons did not need to bovie anymore, so not sure if that resolved the issue".The patient's current condition is reported as "n/a.Bovie spark did not impact the patient's condition".Additional information also states that there were no health consequences to the patient and no medical intervention required.

• Brand Name: WECK DISPOSABLE IMA/ENT 3/4
• 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: 19733929
• Report Number: 3011137372-2024-00097
• Device Sequence Number: 15219322
• Product Code: HGI
• UDI-Device Identifier: 14026704736086
• UDI-Public: (01)14026704736086(11)231001(17)261001(10)1022Z(21)
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K942986
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2024

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
• Device Expiration Date: 10/01/2026
• Device Catalogue Number: 809337
• Device Lot Number: 1022Z
• 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: 06/14/2024
• Supplement Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2023
• 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