FDA Adverse Event
Malfunction
Summary report: N
PROXIMATE ILS CIRCULAR STAPLERS
MDR report key: 583756
·
Received March 16, 2005
Report
- Report Number
- 1527736-2005-01239
- Event Type
- Malfunction
- Date Received
- March 16, 2005
- Date of Event
- February 25, 2005
- Report Date
- February 25, 2005
- Manufacturer
- ETHICON ENDO-SURGERY, INC. (CINCINNATI)
- Product Code
- GAG
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE SURGEON FIRED THE DEVICE. HE REMOVED AND OPENED THE INSTRUMENT AND DID NOT NOTICE AND "DOUGHNUTS" IN THE STAPLER HOUSING. HE INSPECTED THE PT AND NOTICED THAT STAPLES HAD BEEN FORMED BUT THE "DOUGHNUTS" WERE INTACT, NOT TRANSECTED. THE SURGEON ASKED FOR ANOTHER DEVICE AND FIRED THE INSTRUMENT. HE NOTICED THAT THIS INSTRUMENT DID NT TRANSECT THE TISSUE. HE COMPLETED THE CASE BY USING REUSABLE SURGICAL INSTRUMENTS TO REMOVE THE "DOUGHNUTS". THIS PROCESS ADDED 1 1/2 HOURS TO THE SURGEON'S OR TIME. THERE WAS NO PT CONSEQUENCE. TWO DEVICE RETURNING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROXIMATE ILS CIRCULAR STAPLERS | CIRCULAR STAPLERS | GAG | ETHICON ENDO-SURGERY, INC. (CINCINNATI) | NA | PAP14C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |