FDA Adverse Event
Malfunction
Summary report: N
VERSASTEP PLUS 12MM CANN/DILT W/RADEXPS1
MDR report key: 2061367
·
Received March 17, 2011
Report
- Report Number
- 2647580-2011-00185
- Event Type
- Malfunction
- Date Received
- March 17, 2011
- Date of Event
- February 18, 2011
- Report Date
- February 22, 2011
- Manufacturer
- USSC PUERTO RICO
- Product Code
- GCJ
- PMA / PMN Number
- K012539
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: LAPAROSCOPIC NEPHRECTOMY. ACCORDING TO THE REPORTER: DURING THE CASE, THE ATTACHED PART OF SEAL AND SLEEVE WAS TORN. USED OTHER DEVICE. NO BLEEDING. NOTHING FELL INTO THE PATIENT CAVITY. NO TISSUE DAMAGED. NOT EXTENDED MORE THAN 30 MINUTES. NO PATIENT INFO AVAILABLE. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VERSASTEP PLUS 12MM CANN/DILT W/RADEXPS1 | DISPOSABLE SURGICAL ACCESS DEVICE | GCJ | USSC PUERTO RICO | P0G0440 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |