FDA Adverse Event
Injury
Summary report: N
PROXIMATE INTRALUMINAL CIRCULAR STAPLER - 29MM
MDR report key: 463797
·
Received June 4, 2003
Report
- Report Number
- 1527736-2003-00935
- Event Type
- Injury
- Date Received
- June 4, 2003
- Date of Event
- April 28, 2003
- Report Date
- May 14, 2003
- Manufacturer
- ETHICON ENDO-SURGERY, INC. (CINCINNATI)
- Product Code
- GAG
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
RECEIVED USER FACILITY MEDWATCH #14-0105-0001 STATING THAT DURING SEVERAL REVERSALS OF HARTMAN'S PROCEDURE, THE DEVICE USED FOR ANASTOMOSIS DID NOT FIRE AND THE DEVICE DID NOT MAKE COMPLETE DONUTS WHEN FIRED. THIS RESULTED IN THE BOWEL BEING NICKED WHICH REQUIRED REPEAT COLOSTOMY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROXIMATE INTRALUMINAL CIRCULAR STAPLER - 29MM | PROXIMATE ILS CIRCULAR STAPLERS | GAG | ETHICON ENDO-SURGERY, INC. (CINCINNATI) | NA | N4K67P |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention |