MOTOR ASSEMBLY, XMAX
Report
- Report Number
- 1045834-2022-00567
- Event Type
- Malfunction
- Date Received
- May 11, 2022
- Manufacturer
- THE ANSPACH EFFORT LLC
- Product Code
- ERL
- UDI-DI
- 00845384010791
- PMA / PMN Number
- K965080
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
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 REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE OF THIS CONDITION WAS DETERMINED TO BE TRACED TO COMPONENT FAILURE DUE TO WEAR. UDI ¿ (B)(4).
IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE MOTOR DEVICE HAD INSUFFICIENT/LOW POWER, HOSE DAMAGE (EXCLUDING RUPTURE), THE LOCKING MECHANISM WAS STIFF/STUCK, AND THE DEVICE WAS MAKING AN EXCESSIVE NOISE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR HOSE VERIFICATION, CUTTER LOCK ASSESSMENT, NOISE ASSESSMENT, AND ROTATIONAL SPEED ASSESSMENT. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE ISOLATION WAS RIPPED, CORD WAS DAMAGED. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED. 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 |
|---|---|---|---|---|---|---|---|
| 2037941 | MOTOR ASSEMBLY, XMAX | DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) | ERL | THE ANSPACH EFFORT LLC | XMAX | 00845384010791 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |