FDA Adverse Event
Malfunction
Summary report: N
IPC® HANDPIECE - XPS® STRAIGHTSHOT® M4
MDR report key: 9069852
·
Received September 16, 2019
Report
- Report Number
- 1045254-2019-00450
- Event Type
- Malfunction
- Date Received
- September 16, 2019
- Date of Event
- August 6, 2019
- Report Date
- September 16, 2019
- Manufacturer
- MEDTRONIC XOMED INC.
- Product Code
- ERL
- UDI-DI
- 00643169350687
- PMA / PMN Number
- K041413
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
A HEALTH CARE PROVIDER (HCP) REPORTED THAT A HANDPIECE LOCAL TEMPERATURE OF THE MILLING CUTTER GRIP WAS TOO HIGH WHEN THE CUTTER WAS USED FOR CRANIOTOMY, SO THAT THE BONE FLAP COULDN'T BE RELEASED IN TIME, AND IT WAS COOLED AGAIN AFTER BEING COOLED WITH WET GAUZE DURING THE PROCEDURE. THERE WAS NO PATIENT IMPACT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 864664 | IPC® HANDPIECE - XPS® STRAIGHTSHOT® M4 | DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE | ERL | MEDTRONIC XOMED INC. | 1898200T | 209250802 | 00643169350687 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR |