FDA Adverse Event
Summary report: N
AUTO SUTURE DISSECTION BALLOON
MDR report key: 1962559
·
Received January 11, 2011
Report
- Report Number
- 1962559
- Date Received
- January 11, 2011
- Date of Event
- January 10, 2011
- Report Date
- January 11, 2011
- Manufacturer
- COVIDIEN-AUTO SUTURE
- Product Code
- GCJ
- Report Source
- User Facility report
- Reporter Location
- RI, US
Narratives
Description of Event or Problem · 1
WHEN PHYSICIAN WAS USING A DISSECTION BALLOON DURING LAPAROSCOPIC SURGERY THE BALLOON BROKE. HE THEN REMOVED THE BALLOON AND ITS PARTS AND INSPECTED THE ABDOMEN TO BE SURE NO PIECES WERE RETAINED. STAFF NOTIFIED THE GENERAL SURGICAL COORDINATOR WHO PACKAGED AND RETAINED THE BROKEN PIECE OF EQUIPMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AUTO SUTURE DISSECTION BALLOON | AUTO SUTURE DISSECTION BALLOON | GCJ | COVIDIEN-AUTO SUTURE | OMS-PDB 1000 | POK0819 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR |