FDA Adverse Event
Summary report: N
LAPRODRAIN
MDR report key: 1981768
·
Received December 17, 2010
Report
- Report Number
- 3023415-2010-00002
- Date Received
- December 17, 2010
- Date of Event
- November 15, 2010
- Report Date
- December 3, 2010
- Manufacturer
- SURGIMARK, INC.
- Product Code
- JOL
- PMA / PMN Number
- K932689
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
DURING SURGERY THE SURGEON PULLED THE DRAINTOW THROUGH A LAPAROSCOPY PORT AND THE TIP OF THE DRAINTOW SHEARED OFF ASSOCIATED WITH MECHANICAL FORCE APPLIED TO THE PLASTIC TIP WITH A STEEL GRASPING INSTRUMENT. AS A RESULT THE DRAINTOW WAS PARTED INTO TWO PIECES. BOTH PIECES WERE RETRIEVED WITH NO AFFECT ON THE SURGICAL OUTCOME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LAPRODRAIN | NONE | JOL | SURGIMARK, INC. | LD-2007-JP07 | 394128 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR |