FDA Adverse Event Malfunction Summary report: N

VDW GOLD/SILVER CONTRA ANGLE

MDR report key: 12615656 · Received October 12, 2021

Report

Report Number: 9611053-2021-00287
Event Type: Malfunction
Date Received: October 12, 2021
Report Date: October 12, 2021
Manufacturer: DENTSPLY VDW GMBH
Product Code: EGS
PMA / PMN Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NL
Reporter Occupation: DENTIST

Narratives

Additional Manufacturer Narrative · 1

SINCE INCORRECT MEASURE OF AN APEX LOCATOR COULD NECESSITATE MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION, THIS MALFUNCTION WOULD BE LIKELY TO CAUSE/CONTRIBUTE TO A SERIOUS INJURY SHOULD IT RECUR. AS SUCH, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. BATTERY (VOLTAGE COLLAPSES UNDER LOAD) DEFECTIVE, REPLACED. CONTRA-ANGLE HANDPIECE (B)(4) (2012) (ELECTRICAL RESISTANCE OUTSIDE THE NORMAL RANGE) DEFECTIVE, REPAIRED. MICRO MOTOR GMR125245 (DURING THE EXAMINATION OF YOUR DEVICE WE DISCOVERED RESIDUES OF LIQUIDS OR OIL IN YOUR MOTOR. EXCESS OIL THAT REMAINS IN THE CONTRA-ANGLE HANDPIECE AFTER CARE IS THE MOST COMMON CAUSE OF THIS DEFECT. PLEASE CHECK YOUR CARE AND CLEANING PROCESS .) DEFECTIVE, REPLACED WITH GMR 1769952. THE HOUSING HAS CRACKS AND BREAKS, THIS HAS NO EFFECT ON THE FUNCTION. DELIVERY WITHOUT CHARGER, FILE CLIPS AND CABLE. FUNCTION TEST AND TEST MEASUREMENTS WITHOUT ERRORS. TEST CARRIED OUT ACCORDING TO IEC60601.

Description of Event or Problem · 1

IN THIS EVENT IT WAS REPORTED THAT A CONTRA ANGLE 6:1 FOR VDW.GOLD/SILVER CAUSES INCORRECT MEASUREMENT RESULTS WITH A VDW GOLD RECIPROC DEVICE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1513780	VDW GOLD/SILVER CONTRA ANGLE	HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL	EGS	DENTSPLY VDW GMBH	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1