FDA Adverse Event
Malfunction
Summary report: N
CAPIO
MDR report key: 1495788
·
Received September 22, 2009
Report
- Report Number
- 1495788
- Event Type
- Malfunction
- Date Received
- September 22, 2009
- Date of Event
- September 9, 2009
- Report Date
- September 22, 2009
- Manufacturer
- BOSTON SCIENTIFIC CORP.
- Product Code
- FHQ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- NY, US
Narratives
Description of Event or Problem · 1
CAPIO SUTURE DEVICE DID NOT ALIGN PROPERLY # M0068317050, LOT# OML9050701, AND EXP DATE 2010-05. A SECOND DEVICE FAILED. THE CATCH DEVICE WOULD NOT RETRIEVE THE SUTURE, CAPIO # 831-125, LOT # 12276218, EXP DATE 2011-12. A THIRD DEVICE WAS USED WITHOUT FURTHER OCCURRENCE.
Description of Event or Problem · 1
CAPIO SUTURE DEVICE DID NOT ALIGN PROPERLY # M0068317050, LOT# OML9050701, AND EXP DATE 2010-05. A SECOND DEVICE FAILED. THE CATCH DEVICE WOULD NOT RETRIEVE THE SUTURE, CAPIO # 831-125, LOT # 12276218, EXP DATE 2011-12. A THIRD DEVICE WAS USED WITHOUT FURTHER OCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAPIO | SUTURE CAPTURING DEVICE | FHQ | BOSTON SCIENTIFIC CORP. | * | OML9050701 | |
| 2 | CAPIO | SUTURE CAPTURING DEVICE | FHQ | BOSTON SCIENTIFIC CORP. | * | 12276218 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR |