FLEXIVA ID
Report
- Report Number
- 15013260
- Event Type
- Malfunction
- Date Received
- July 14, 2022
- Date of Event
- June 27, 2022
- Report Date
- June 30, 2022
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- GEX
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- ME
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
NARRATIVE FROM STAFF: DURING OUR CASE, WE OPENED A FLEXIVA ID 1000 AND PLUGGED END INTO LASER MACHINE. THE MACHINE HAD A CIRCLE THAT KEPT CIRCLING BUT WOULD NOT LOAD/READ IT. WE HAD PREVIOUSLY USED THE 550 LASER AND IT WORKED FINE SO IT WASN'T THE LASER MACHINE. WE UNPLUGGED THE 1000 ONE AND PLUGGED THE 550 ONE BACK IN AND IT READ FINE AND WERE ABLE TO USE IT. THIS FLEXIVA ID 1000 CAME DEFECTIVE.
NARRATIVE FROM STAFF: DURING OUR CASE, WE OPENED A FLEXIVA ID 1000 AND PLUGGED END INTO LASER MACHINE. THE MACHINE HAD A CIRCLE THAT KEPT CIRCLING BUT WOULD NOT LOAD/READ IT. WE HAD PREVIOUSLY USED THE 550 LASER AND IT WORKED FINE SO IT WASN'T THE LASER MACHINE. WE UNPLUGGED THE 1000 ONE AND PLUGGED THE 550 ONE BACK IN AND IT READ FINE AND WERE ABLE TO USE IT. THIS FLEXIVA ID 1000 CAME DEFECTIVE.
NARRATIVE FROM STAFF: DURING OUR CASE, WE OPENED A FLEXIVA ID 1000 AND PLUGGED END INTO LASER MACHINE. THE MACHINE HAD A CIRCLE THAT KEPT CIRCLING BUT WOULD NOT LOAD/READ IT. WE HAD PREVIOUSLY USED THE 550 LASER AND IT WORKED FINE SO IT WASN'T THE LASER MACHINE. WE UNPLUGGED THE 1000 ONE AND PLUGGED THE 550 ONE BACK IN AND IT READ FINE AND WERE ABLE TO USE IT. THIS FLEXIVA ID 1000 CAME DEFECTIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1955297 | FLEXIVA ID | POWERED LASER SURGICAL INSTRUMENT | GEX | BOSTON SCIENTIFIC CORPORATION | M006R8403940 | 0000010893 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |