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

Model Number	IPN029474
Medical Device Problem Codes	Overheating of Device (1437); Flare or Flash (2942)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).Customer was making incision with 809335, eschar remained on the tip of the electrode.When activated again, the eschar ignited for 2 seconds, causing a flame.The surgeon stopped using the device.Surgery completed was left video assisted thoracoscopy, left lower lobe completion lobectomy, mediastinal lymph node dissection.The customer confirmed there was buildup of eschar on the device during the time of the event.Complaint confirmed from information received from customer.The root cause is user error in not removing flammable material from activation site.The ifu was reviewed which states, "fire hazard: the sparking and heating associated with electrosurgery can provide an ignition source.Observe fire precautions at all times: tissue buildup (eschar) on the tip of an active electrode poses a fire hazard, especially in oxygen enriched environments.With sufficient heating, eschar can become a glowing ember and pose a fire hazard both as an ignition source and as a fuel.Keep the electrode clean and free of all debris." containment actions are not necessary as the product has been used and does not represent product in inventory accurately.Corrective action is not required per the root cause and the risk assessment.Hhe not required because risk level is not catastrophic severity and the clinical safety of patients and/or users is not in question.Preventative action is not required per the root cause and the risk assessment.The customer was advised to use essp scratch pad to remove eschar in future surgeries.Verification of effectiveness is not required per the root cause and the risk assessment.
Event or Problem Description
Reported issue: shortly after making incision size of approximately 3-4cm, while using plumepen ultra cautery device on the incision edges with a short insulated bovie tip, debris collected onto the bovie tip, both the insulated and non-insulated surfaces and caught on fire.Flame ignited quickly and self-extinguished; total time of combustion was approximately 2 seconds.The surgeon stopped using the device immediately upon seeing the flame.There was no reported injury.

• Brand Name: DISP. IMA/ENT 3/4 BLADE ELECTRODE
• Common Device Name: ELECTROCAUTERY, GYNECOLOGIC
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16486415
• Report Number: 3003898360-2023-00382
• Device Sequence Number: 5849331
• Product Code: HGI
• UDI-Device Identifier: 14026704646019
• UDI-Public: 14026704646019
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/08/2023

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: IPN029474
• Device Catalogue Number: 809335
• Device Lot Number: 0421G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2023
• Initial Report FDA Received Date: 03/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED
• Patient Sex: Unknown