FDA Adverse Event
Injury
Summary report: N
SM PLUS SBT/OVAL BALLOON DISSECTOR
MDR report key: 1024773
·
Received April 2, 2008
Report
- Report Number
- 1219930-2008-00267
- Event Type
- Injury
- Date Received
- April 2, 2008
- Date of Event
- March 17, 2008
- Report Date
- March 17, 2008
- Manufacturer
- NORTH HAVEN - USS
- Product Code
- GDI
- PMA / PMN Number
- K042412
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE INITIAL REPORT SENT: 04/02/2008.
Description of Event or Problem · 1
PROCEDURE TYPE: INGUENAL HERNIA REPAIR. ACCORDING TO THE REPORTER: UPON REMOVING THE DISSECTOR BALLOON, IT CAUGHT ON THE ACCESS (STRUCTURAL) BALLOON CANNULA AND IT BURST WHILE IN THE CAVITY. THE SURGEON REMOVED A PORTION OF THE BALLOON, BUT HIS WAS UNCERTAIN IF ALL PIECES WERE REMOVED. THE PERITONEUM SPACE WAS COMPROMISED AND SOME BLEEDING WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SM PLUS SBT/OVAL BALLOON DISSECTOR | DISPOSABLE SURGICAL ACCESS DEVICE | GDI | NORTH HAVEN - USS | U7J46 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |