FDA Adverse Event
Injury
Summary report: N
ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45 MM STAPLE LINE -
MDR report key: 1022849
·
Received March 26, 2008
Report
- Report Number
- 1527736-2008-01867
- Event Type
- Injury
- Date Received
- March 26, 2008
- Date of Event
- March 4, 2008
- Report Date
- March 7, 2008
- Manufacturer
- ETHICON ENDO SURGERY, INC (CINCINNATI)
- Product Code
- GDW
- PMA / PMN Number
- K020779
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE SENT: 3/26/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A RECTAL RESECTION PROCEDURE, THEY STAPLED PART OF BOWEL AND PART OF THE STAPLES WERE MALFORMED AND CUT THE TISSUE. TISSUE "UNZIPPED" WITH BOWEL CONTENT SPILLING INTO ABDOMEN. OPENED WITH A PFANNENSTIEL INCISION AND SUTURED LAPAROSCOPICALLY. PATIENT HAD TO BE TREATED WITH ANTIBIOTICS FOR INFECTION DUE TO BOWEL CONTENTS CONTAMINATION OF PELVIS. THE PROCEDURE WAS PROLONGED 60 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45 MM STAPLE LINE - | GDW | ETHICON ENDO SURGERY, INC (CINCINNATI) | NA | D4JK4G |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |