FDA Adverse Event
Malfunction
Summary report: N
ENDO LINEAR CUTTERS-ETS45MM
MDR report key: 738336
·
Received July 17, 2006
Report
- Report Number
- 1527736-2006-03332
- Event Type
- Malfunction
- Date Received
- July 17, 2006
- Date of Event
- June 26, 2006
- Report Date
- July 11, 2006
- Manufacturer
- ETHICON ENDO-SURGERY, INC.(CINCINNATI)
- Product Code
- GDW
- PMA / PMN Number
- k020779
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SN
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFO IS ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAPAROSCOPIC ANTERIOR RESECTION PROCEDURE, 2ND FIRING OF BLUE RELOADED WAS USED ON DISTAL BOWEL RESECTION. UPON TAKING OUT OF SPECIMEN, IT WAS FOUND THAT 2ND FIRING OF BLUE RELOADS DID NOT ENGAGE WHILE KNIFE WAS CUT THROUGH OUT TISSUE. NO STAPLES WERE FOUND ON EITHER SIDE OF COLON ON 2ND RELOAD. ANOTHER RELOAD WAS NEEDED TO TRANSECT DISTAL COLON BELOW FAULTY STAPLE LINE CAUSED BY THE 2ND BLUE RELOAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO LINEAR CUTTERS-ETS45MM | GDW | GDW | ETHICON ENDO-SURGERY, INC.(CINCINNATI) | NA | C4DJ35 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |