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

Catalog Number 809337

Device Problem Fire (1245)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/27/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device investigation report has not been submitted at this time.Teleflex will continue to monitor and trend related events.

Event Description

The item caught on fire while in use.There was no harm to the patient.

Manufacturer Narrative

(b)(4).Dhr was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns.No concerns were noted with reference to 809337.1) sample of 809337 was received for evaluation.Lot # unknown.The device is blackened around the tip and organic material is encrusted along the insulated shaft.The surface was gently scraped to remove the encrusted organic material under magnification to expose the base instrument.Several fibers were suspended in the organic material which appeared to be a mixture of hair and cotton fibers.After cleaning the base instrument was inspected.The insulation which surrounds the working shaft was intact a small area near the tip showed signs of charring from the fire event.The device was inspected under high magnification for signs of electrical arcing.No evidence of arcing damage through the dielectric could be found.The needle point shows signs of electrical arcing at the point of the sharpened tip which is the intended point of patient contact.Electrical arcing should never occur during use.This only happens when the electrode is not in contact with the patient when the energy is engaged.Electrical power was other remarks: conducted to the "point of use" as was designed.There are no moving or functioning "parts" in this device.There is no measureable damage to the device.It was present in the "fire" but did not contribute any oxidized material to the fire event.Potential root causes of the fire are one or more user error(s) including- presence of combustible material at usage point.Inadequate contact with patient or power settings too high accidental direct contact with ground plane.After extensive examination of the electrode it was determined that the electrode may have initiated the fire - but this was not the result of a device failure.(b)(4).

Event Description

The item caught on fire while in use.There was no harm to the patient.

• Brand Name: DISP. IMA/ENT 3/4 NEEDLE ELECTRODE
• Type of Device: ELECTROCAUTERY,GYNECOLOGIC,ACCESSO
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 6701448
• MDR Text Key: 79884146
• Report Number: 3011137372-2017-00234
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K942986
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 809337
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1