FDA Adverse Event Injury Summary report: N

ELCOMED SURGICAL HANDPIECE / DRILL

MDR report key: 16700278 · Received April 7, 2023

Report

Report Number
MW5116402
Event Type
Injury
Date Received
April 7, 2023
Date of Event
March 24, 2023
Report Date
March 31, 2023
Manufacturer
W&H DENTALWERK BUERMOOS GMBH
Product Code
KMW
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
PHYSICIAN
Health Professional
Yes

Narratives

Description of Event or Problem · 0

PT WAS HAVING REMOVAL OF HER WISDOM TEETH, WHICH REQUIRES REMOVAL OF BONE AND SECTIONING OF TEETH WITH A HIGH-SPEED ROTARY INSTRUMENT. WE USE A SURGICAL STRAIGHT HANDPIECE WITH A MOTOR THAT RUNS AT STANDARD 50,000 RPM (MFR: W&H ELCOMED). A 702 CARBIDE BUR WAS USED WITH COPIOUS NORMAL SALINE IRRIGATION. I ALWAYS USE MY FINGERS TO HOLD THE LIP / CHEEK OUT TO NOT ONLY GET MORE LIGHT INTO THE FIELD, BUT ALSO TO AVOID TRAUMA FROM THE BUR. A FEW MINS AFTER SECTIONING TOOTH #47, MY ASSISTANT NOTICED A DEEP (3RD DEGREE) BURN TO THE LEFT LIP COMMISSURE, EVIDENTLY AS A RESULT OF THE SHAFT OF THE HANDPIECE HAVING CONTACT WITH TISSUES WHILE IN USE. THIS IS EXPECTED. WE USE SURGICAL HANDPIECES EVERYDAY, BUT I HAVE NEVER ENCOUNTERED A BURN LIKE THIS BEFORE. I DID NOT FEEL ANY HEAT GENERATED BY THE HANDPIECE ITSELF, AND WE DIDN'T ACTUALLY EVEN SEE THE BURN UNTIL A MIN OR 2 LATER, ALMOST AS IF IT WAS A DELAYED REACTION TO WHATEVER HEAT OR VIBRATION WAS BEING GENERATED BY THE HANDPIECE. TO CLARITY IT WAS NOT THE BUR, BUT RATHER THE SHAFT OF THE HANDPIECE VS, MOTOR ITSELF. I COULDN'T TELL WHICH WAS RESPONSIBLE. THE BURN WAS FULL THICKNESS INTO MUSCLE. THOUGH THERE WAS NOT EVEN ANY BLEEDING FROM THE WOUND. NO SIGNS OF TRAUMA WERE IDENTIFIED INTRAORALLY. THE SITE OF BURN WAS APPROX 5X5MM FULL-THICKNESS THROUGH LIP COMMISSURE ON LEFT, FROM MUCOSA OUT TO THE SKIN. IT WAS CLEANSED, INSPECTED, AND CLOSED WITH DEEP SUTURES 4-0 VICRYL AND 5-0 FAST ABSORBING GUT ON THE SKIN, TAKING CARE TO ALIGN THE VERMILLION BORDER. DRESSING WITH STERRI STRIPS WAS APPLIED. PT WAS NOTIFIED OF INCIDENT AND INSTRUCTED TO RETURN IN 1WK TO EVALUATE, REMOVE DRESSING AND POSSIBLY SUTURES. SHE DID NOT RETURN FOR HER FOLLOW-UP. REF REPORT: MW5116403.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1730509 ELCOMED SURGICAL HANDPIECE / DRILL HANDPIECE, ROTARY BONE CUTTING KMW W&H DENTALWERK BUERMOOS GMBH S-11

Patients

Seq Age Sex Outcome Treatment
1 20 YR Female Required Intervention CONSOLE