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U.S. Department of Health and Human Services

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

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TELEFLEX MEDICAL DISP. IMA/ENT 3/4 NEEDLE ELECTRODE ELECTROCAUTERY,GYNECOLOGIC,ACCESSO Back to Search Results
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.
 
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Brand NameDISP. IMA/ENT 3/4 NEEDLE ELECTRODE
Type of DeviceELECTROCAUTERY,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 Key6701448
MDR Text Key79884146
Report Number3011137372-2017-00234
Device Sequence Number1
Product Code HGI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K942986
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/27/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/11/2017
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number809337
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/05/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/12/2017
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

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