CAUTERY HIGH TEMP LOOP TIP AA03

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-15 for CAUTERY HIGH TEMP LOOP TIP AA03 manufactured by Bovie Medical Corp..

Event Text Entries

[92060512] A meatotomy was being performed on a (b)(6) year old patient, who was under a mac with oxygen being supplied via face mask. The fire risk was deemed a "2" at the start of the procedure. Pdi povidone - iodine swabstick (non-alcohol) was used as a pre-operative skin preparation and allowed to dry thoroughly. Water was placed on the back table. The surgical area was draped in cloth. Towards the very end of the procedure, the physician requested a disposable bovie (bovie medical corp, model aa03; cautery high temp loop tip) to accomplish hemostasis. The physician "zapped" the incision site once and was preparing to "zap" the site a 2nd time. It is suspected that when the bovie had been used the first time, some tissue may have remained on the tip. When the bovie was activated the second time, the tissue may have dislodged and landed on a 4 "x8" ray-tech sponge that was about 5" from the surgical site. The tissue ignited the edge of the sponge. The operating room tech quickly brought the container of sterile water onto the field while the physician's assistant was able to pick up the sponge and submerge it in the water to extinguish the fire. No injuries occurred. The crna was able to turn down the oxygen supply and ensure the mask was tight fitting to minimize excess oxygen escaping. The circulating rn was able to place a cautery pad and connect a reusable monopolar cautery quickly and hand it to the physician so the surgery could be completed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5073339
MDR Report Key7032631
Date Received2017-11-15
Date of Report2017-11-13
Date of Event2017-11-06
Date Added to Maude2017-11-15
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCAUTERY HIGH TEMP LOOP TIP
Generic NameCAUTERY
Product CodeHQP
Date Received2017-11-15
Model NumberAA03
Catalog NumberAA03
Device Expiration Date2018-01-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerBOVIE MEDICAL CORP.
Manufacturer Address5115 ULMERTON RD. CLEARWATER FL 33760 US 33760


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-11-15

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