FDA Adverse Event Malfunction Summary report: N

MOTOR ASSEMBLY, XMAX

MDR report key: 12682853 · Received October 22, 2021

Report

Report Number: 1045834-2021-01694
Event Type: Malfunction
Date Received: October 22, 2021
Date of Event: October 13, 2021
Report Date: October 18, 2021
Manufacturer: THE ANSPACH EFFORT LLC
Product Code: ERL
UDI-DI: 00845384010791
PMA / PMN Number: K965080
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THIS MEDWATCH, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED AS APPROPRIATE. ADDITIONAL NARRATIVE: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. DURING REPAIR, AN EVALUATION WAS PERFORMED AND IT WAS DETERMINED THAT THE DEVICE WAS LEAKING LIQUID AND WOULD NOT RUN. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE TRACED TO THE USER, WHICH IS USER ERROR. UDI: (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE MOTOR DEVICE HAD WORN VANES, COMPONENT DAMAGE, WOULD NOT RUN, AND WAS LEAKING LIQUID. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR MUFFLER TUBE VERIFICATION, AND OIL LEAK. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD NO POWER DURING AN UNSPECIFIED SURGICAL PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1582995	MOTOR ASSEMBLY, XMAX	DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC)	ERL	THE ANSPACH EFFORT LLC	XMAX		00845384010791

Patients

Seq	Age	Sex	Outcome	Treatment
1