MAUDE Adverse Event Report: MICROAIRE SURGICAL INSTRUMENTS 1000ET ELECTRIC MOTOR MODULE W /HAND THROTTLE; MOTOR, SURGICAL INSTRUMENT PNEUMATIC POWERED

Device Problem Overheating of Device (1437)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 08/02/2019

Event Type  Injury  

Event Description

During a left revision total hip arthroplasty (tha) the microaire hand piece with burr was placed on the drape over the pt's left flank for a period of time between uses.The device overheated, causing a burn to the pt's left flank.The pt was brought to the operating room and placed under general anesthesia with a regional block.The pt was placed on his right side with a folded blanket placed over the pt's upper body.Draping was done in the usual manner.Draping over the upper body included a plastic down sheet placed over the blanket, followed by a u-drape, and a heavy hip drape over all.The surgeon was positioned on the pt's left side (to the pt's back).The scrub tech was positioned at the foot of the bed, with a mayo stand positioned on either side of the foot of the bed (to the surgeon's left side).The surgeon is right handed.During the course of surgery, a microaire hand piece with burr attachment was used to aid in the extraction of the femoral implant.Following use, the surgeon placed the hand piece safety switch on "safe" and laid the device on a doubled lap sponge on the drape over the pt's upper flank (to the right of the surgeon) for an unk period of time.The surgeon later picked up the hand piece for add'l use, switched it to "run" and immediately noted it was hot, causing him to drop the device to the floor.The sponge and drapes where the device had been laid were noted to be burned / melted.The pt's skin was visualized under the drape by the anesthesiologist, who noted erythematous skin changes consistent with a burn.The sterility of that location of the drape was considered compromised, was re-draped and the procedure completed.At the conclusion of surgery, it was noted that the pt had sustained a full thickness burn to the left flank.Bacitracin ointment and a dressing was applied.The pt was followed by plastic surgeon, who saw the pt as an outpatient and performed a partial excision of the burned area.Fda safety report id# (b)(4).

• Brand Name: 1000ET ELECTRIC MOTOR MODULE W /HAND THROTTLE
• Type of Device: MOTOR, SURGICAL INSTRUMENT PNEUMATIC POWERED
• Manufacturer (Section D): MICROAIRE SURGICAL INSTRUMENTS ; charlottesville VA 22911
• MDR Report Key: 8949621
• MDR Text Key: 156112246
• Report Number: MW5089458
• Device Sequence Number: 1
• Product Code: GET
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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
• Treatment: MICROAIRE CONSOLE MODEL 1025 ; SHANNON BUR ZB-192
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 101