FDA Adverse Event Injury Summary report: N

SANAO

MDR report key: 4693921 · Received March 20, 2015

Report

Report Number: 3006028656-2015-00923
Event Type: Injury
Date Received: March 20, 2015
Manufacturer: SCICAN GMBH
Product Code: EGS
PMA / PMN Number: K132539
Report Source: Manufacturer report

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE AGE AND WEIGHT OF THE PATIENT ARE A BEST ESTIMATE. THE PATIENT IDENTIFIER WAS ALSO NOT INCLUDED AS NO PATIENT INFORMATION COULD BE OBTAINED FROM THE DENTIST. THE DENTIST HAS ONLY RECENTLY AGREED TO RETURN THE HANDPIECE, THEREFORE THE MANUFACTURER HAS NOT YET HAD THE OPPORTUNITY TO EVALUATE THE DEVICE. HOWEVER IT SHOULD FINALLY BE RETURNED TO THE IMPORTER BY (B)(4) 2015. IT WILL THEN IMMEDIATELY BE RETURNED TO US, THE MANUFACTURER IN (B)(4), AND AN INVESTIGATION CAN BE PERFORMED ON THE HANDPIECE. THE FOLLOWING SAFETY INFORMATION HAS BEEN PROVIDED IN THE IFU WITH REGARD TO THE USE OF ELECTRIC MICRO-MOTORS: "RISKS WHEN USING HANDPIECES WITH ELECTRICAL MOTOR-MOTORS. ELECTRICAL MICRO-MOTORS GENERATE SIGNIFICANTLY MOR ENERGY THAN CONVENTIONAL AIR TURBINES AND AIR MOTORS. DUE TO THE HIGH TORQUES AND SPEEDS, POORLY SERVICED, DAMAGED OR MISUSED HANDPIECES MAY LEAD TO THE OVERHEATING WHICH COULD INFLICT SEVERE BURNS ON THE PATIENT.

Description of Event or Problem · 1

(B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
190543	SANAO	HANDPIECE, ATTACHMENT, DENTAL	EGS	SCICAN GMBH

Patients

Seq	Age	Sex	Outcome	Treatment
1