FDA Adverse Event
Malfunction
Summary report: N
PROXIMATE INTRALUMINAL CIRCULAR STAPLER
MDR report key: 488125
·
Received October 6, 2003
Report
- Report Number
- 1527736-2003-01989
- Event Type
- Malfunction
- Date Received
- October 6, 2003
- Date of Event
- September 15, 2003
- Manufacturer
- ETHICON ENDO-SURGERY, INC. (CINCINNATI)
- Product Code
- GAG
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TU
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE, DURING THE PROCEDURE, WHEN THE SURGEON SQUEEZED THE TRIGGER OF THE DEVICE TO BE FIRED, THE STAPLER DID NOT REPLACE THE STAPLES ON THE POSTERIOR WALL AND THUS WAS NOT ABLE TO CUT IT. THERE WERE ONLY A FEW STAPLES REPLACED ON THE ANTERIOR WALL. NO PT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROXIMATE INTRALUMINAL CIRCULAR STAPLER | PROXIMATE ILS CIRCULAR STAPLERS | GAG | ETHICON ENDO-SURGERY, INC. (CINCINNATI) | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |