FDA Adverse Event
Injury
Summary report: N
PROXIMATE RELOADABLE LINEAR CUTTER WITH SAFETY LOCK-OUT
MDR report key: 691059
·
Received March 22, 2006
Report
- Report Number
- 1527736-2006-01280
- Event Type
- Injury
- Date Received
- March 22, 2006
- Date of Event
- February 27, 2006
- Report Date
- February 27, 2006
- Manufacturer
- ETHICON ENDO-SURGERY, INC.
- Product Code
- GAG
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. 510(K)# IS K020779.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS USED DURING A GASTRIC BYPASS REVISION PROCEDURE. A LEAK IN THE STAPLE LINE WAS NOTICED ON A CT SCAN. THE PATIENT WAS TAKEN BACK TO SURGERY. NO OTHER INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROXIMATE RELOADABLE LINEAR CUTTER WITH SAFETY LOCK-OUT | GDW | GAG | ETHICON ENDO-SURGERY, INC. | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |