FDA Adverse Event
Malfunction
Summary report: N
PROXIMATE LINEAR CUTTER RELOAD - THICK
MDR report key: 1190789
·
Received October 7, 2008
Report
- Report Number
- 3005075853-2008-02180
- Event Type
- Malfunction
- Date Received
- October 7, 2008
- Date of Event
- September 17, 2008
- Report Date
- September 22, 2008
- 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
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE STAPLES WOULD NOT HOLD. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROXIMATE LINEAR CUTTER RELOAD - THICK | GDW | ETHICON ENDO-SURGERY, LLC. | NA | D4H76P |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |