MAUDE Adverse Event Report: BOVIE MEDICAL CORP. CAUTERY HIGH TEMP LOOP TIP

Model Number AA03

Device Problem Fire (1245)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/06/2017

Event Type  Injury  

Event Description

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.

• Brand Name: CAUTERY HIGH TEMP LOOP TIP
• Type of Device: CAUTERY
• Manufacturer (Section D): BOVIE MEDICAL CORP.; 5115 ulmerton rd.; clearwater FL 33760
• MDR Report Key: 7032631
• MDR Text Key: 92060512
• Report Number: MW5073339
• Device Sequence Number: 1
• Product Code: HQP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2018
• Device Model Number: AA03
• Device Catalogue Number: AA03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/15/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 5 YR
• Patient Weight: 21