FDA Adverse Event
Malfunction
Summary report: N
SM PLUS SBT/OVAL BALLOON DISSECTOR
MDR report key: 2133271
·
Received May 11, 2011
Report
- Report Number
- 2647580-2011-00306
- Event Type
- Malfunction
- Date Received
- May 11, 2011
- Date of Event
- April 8, 2011
- Report Date
- April 8, 2011
- Manufacturer
- USSC PUERTO RICO
- Product Code
- GCJ
- PMA / PMN Number
- K042412
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: INGUINAL HERNIA REPAIR. ACCORDING TO THE REPORTER: BALLOON DID NOT DEPLOY TO CREATE SPACE IN THE EXTRAPERITONEAL CAVITY. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 250CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO TISSUE DAMAGE OR UNANTICIPATED TISSUE LOSS. A NEW INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SM PLUS SBT/OVAL BALLOON DISSECTOR | DISPOSABLE SURGICAL ACCESS DEVICE | GCJ | USSC PUERTO RICO | P1C0251 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR |