FDA Adverse Event
Injury
Summary report: N
ENDOPATH ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29 MM
MDR report key: 1363105
·
Received April 15, 2009
Report
- Report Number
- 3005075853-2009-02336
- Event Type
- Injury
- Date Received
- April 15, 2009
- Date of Event
- March 25, 2009
- Report Date
- March 26, 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
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING LAP SIGMOID PROCEDURE, THE DONUTS WERE GOOD, BUT DURING THE LEAK TEST, IT WAS VISUALLY NOTED THAT THERE WERE LOTS OF BUBBLES. LEAKAGE WAS CONFIRMED. THE PHYSICIAN HAD TO PERFORM A TEMPORARY ILEOSTOMY ON THE PATIENT. SURGERY WAS PROLONGED FORTY FIVE MINS. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.
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 | E4MJ50 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |