FDA Adverse Event
Injury
Summary report: N
BLADELESS VP 5MM ST W/ FIXATION
MDR report key: 2121443
·
Received June 7, 2011
Report
- Report Number
- 1219930-2011-00485
- Event Type
- Injury
- Date Received
- June 7, 2011
- Date of Event
- May 24, 2011
- Report Date
- May 25, 2011
- Manufacturer
- UNITED STATES SURGICAL
- Product Code
- GCJ
- PMA / PMN Number
- K081169
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: OOPHOROCYSTECTOMY. ACCORDING TO THE REPORTER: WHEN THE DEVICE WAS INSERTED, THE BLUE PART OF THE DILATION SHIELD WAS SEEN THROUGH MEMBRANES OF THE ABDOMEN, NOT THE TIP OF THE DEVICE. IT WAS FOUND THAT THE FIN AND THE SHIELD HAD BROKEN. THE SURGERY WAS DONE WITH THE DEVICE. AFTER THE DEVICE WAS REMOVED, THE SHIELD COULD NOT BE FOUND. IT MIGHT REMAIN IN CAVITY. NO BLEEDING WAS REPORTED. NO TISSUE DAMAGE WAS REPORTED. OPERATING TIME WAS EXTENDED MORE THAN 30 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BLADELESS VP 5MM ST W/ FIXATION | DISPOSABLE SURGICAL ACCESS DEVICE | GCJ | UNITED STATES SURGICAL | N1C0718J |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |