FDA Adverse Event
Injury
Summary report: N
ENDOPATH ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29 MM
MDR report key: 1359736
·
Received April 10, 2009
Report
- Report Number
- 3005075853-2009-02213
- Event Type
- Injury
- Date Received
- April 10, 2009
- Date of Event
- March 12, 2009
- Report Date
- March 18, 2009
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- FHM
- PMA / PMN Number
- K940967
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFO IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT FOUR DAYS POST-OP A LAP SIGMOID COLECTOMY PROCEDURE, THERE WAS DEHISCENCE ON THE RIGHT POSTERIOR SIDE OF THE ANASTOMOSIS. AN OPEN RESECTION WAS PERFORMED TO RE-DO THE ANASTOMOSIS. THE PT RECEIVED A TEMPORARY COLOSTOMY AND CURRENTLY REMAINS IN THE HOSP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29 MM | FHM | ETHICON ENDO-SURGERY, LLC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |