FDA Adverse Event
Malfunction
Summary report: N
PROXIMATE ILS CURVED CIR STAPL
MDR report key: 1822204
·
Received December 3, 2007
Report
- Report Number
- 1527736-2007-08183
- Event Type
- Malfunction
- Date Received
- December 3, 2007
- Date of Event
- November 7, 2007
- Report Date
- November 12, 2007
- Manufacturer
- ETHICON ENDO-SURGERY, INC. (CINCINNATI)
- Product Code
- GDW
- PMA / PMN Number
- K983536
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SI
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN UNK PROCEDURE THERE WAS NO STAPLE FORMATION AND THE ANASTOMOSIS WAS NOT FORMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME LIKE DEVICE. THE PATIENT WAS IN STABLE CONDITION IMMEDIATELY FOLLOWING THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROXIMATE ILS CURVED CIR STAPL | GDW | ETHICON ENDO-SURGERY, INC. (CINCINNATI) | NA | D4GG3M |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |