FDA Adverse Event
Malfunction
Summary report: N
SPEEDBAND SUPERVIEW SUPER 7 LIGATOR
MDR report key: 1230352
·
Received November 7, 2008
Report
- Report Number
- 3005099803-2008-06144
- Event Type
- Malfunction
- Date Received
- November 7, 2008
- Date of Event
- October 7, 2008
- Report Date
- October 9, 2008
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- MND
- PMA / PMN Number
- K020824
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE SUSPECT DEVICE HAS BEEN DISPOSED. A DEVICE EVAL WILL NOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A VARICEAL BANDING PROCEDURE, THE BANDS WOULD NOT FIRE. THE CASE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PT IS REPORTED TO BE "FINE".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPEEDBAND SUPERVIEW SUPER 7 LIGATOR | MND | BOSTON SCIENTIFIC CORPORATION | M00542251 | 11993481 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR |