FDA Adverse Event
Summary report: N
PROX ACCESS 55MM ART STAP THIC
MDR report key: 705377
·
Received October 14, 2005
Report
- Report Number
- 1527736-2005-04732
- Date Received
- October 14, 2005
- Date of Event
- September 21, 2005
- Report Date
- September 22, 2005
- Manufacturer
- ETHICON ENDO-SURGERY, INC.
- Product Code
- GAG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
TRACKING#426977-0 DATE SENT: 11/17/2005 ADDITIONAL INFORMATION: D4, 10; G4; H2, 3,4,6 INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.
Description of Event or Problem · 1
DURING A SIGMOID COLON RESECTION, NO STAPLE CAME OUT OF THE DEVICE. AS A RESULT, STOOL SPILLED INSIDE THE PATIENT'S ABDOMEN. THE PROCEDURE WAS COMPLETED BY HAND-SUTURING. OR TIME EXTENDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROX ACCESS 55MM ART STAP THIC | ARTICULATING LINEAR STAPLER | GAG | ETHICON ENDO-SURGERY, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |