FDA Adverse Event
Malfunction
Summary report: N
PROXIMATE** RELOADABLE LINEAR CUTTER WITH SAFTEY LOCK-OUT
MDR report key: 2884755
·
Received December 25, 2012
Report
- Report Number
- 3005075853-2012-05860
- Event Type
- Malfunction
- Date Received
- December 25, 2012
- Date of Event
- December 2, 2012
- Report Date
- December 17, 2012
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- GDW
- PMA / PMN Number
- K020779
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Additional Manufacturer Narrative · 1
(B)(4). ATTEMPTS HAVE BEEN MADE TO HAVE DEVICE RETURNED. DEVICE LOCATION IS UNKNOWN.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, STAPLES WOULD NOT DEPLOY. THE STAFF PULLED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROXIMATE** RELOADABLE LINEAR CUTTER WITH SAFTEY LOCK-OUT | STAPLE, IMPLANTABLE | GDW | ETHICON ENDO-SURGERY, LLC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |