FDA Adverse Event
Malfunction
Summary report: N
PROXIMATE** LINEAR STAPLER
MDR report key: 3943397
·
Received July 18, 2014
Report
- Report Number
- 3005075853-2014-05068
- Event Type
- Malfunction
- Date Received
- July 18, 2014
- Date of Event
- June 23, 2014
- Report Date
- July 11, 2014
- 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
- DC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE DID NOT STAPLE. IT WAS UNKNOWN WHICH FIRING THIS OCCURRED ON. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE. DEVICE WAS DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 422495 | PROXIMATE** LINEAR STAPLER | STAPLE, IMPLANTABLE | GDW | ETHICON ENDO-SURGERY, LLC. | NA | L4E799 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | RELOAD-TR60 - LOT # G4RC2H |