FDA Adverse Event
Malfunction
Summary report: N
VERSASTEP PLUS 12MM CANN/DILT W/RADEXPSL
MDR report key: 2052434
·
Received March 16, 2011
Report
- Report Number
- 2647580-2011-00179
- Event Type
- Malfunction
- Date Received
- March 16, 2011
- Date of Event
- February 3, 2011
- Report Date
- February 20, 2011
- Manufacturer
- USSC PUERTO RICO
- Product Code
- GCJ
- PMA / PMN Number
- K012539
- 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: LAPARO GYN. ACCORDING TO THE REPORTER: AFTER INSERTED, IT WAS FOUND THAT THE GIMBAL SEAL HAD COMPLETELY COME OFF. USED OTHER DEVICE. NO BLEEDING. NOTHING FELL INTO THE PT CAVITY. NO TISSUE DAMAGED. NOT EXTENDED MORE THAN 30 MINUTES. NO PT INFO AVAILABLE. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VERSASTEP PLUS 12MM CANN/DILT W/RADEXPSL | DISPOSABLE SURGICAL ACCESS DEVICE | GCJ | USSC PUERTO RICO | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |