FDA Adverse Event
Injury
Summary report: N
ENDOPATH ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 33 MM
MDR report key: 1370505
·
Received April 28, 2009
Report
- Report Number
- 3005075853-2009-02510
- Event Type
- Injury
- Date Received
- April 28, 2009
- Date of Event
- March 19, 2009
- Report Date
- April 2, 2009
- Manufacturer
- ETHICON ENDO-SURGERY, LLC
- Product Code
- FHM
- PMA / PMN Number
- K940967
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID, US
- 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 A LAPAROSCOPIC COLECTOMY PROCEDURE, THE DEVICE WAS USED AS INTENDED. POST OPERATIVELY THE PATIENT WAS ABOUT TO HAVE A BOWEL MOVEMENT AND BEGAN TO EXPERIENCE PAIN. THEY FOUND THAT THE ANVIL WAS LEFT IN THE PATIENT AND IT WAS ABOUT TO PASS. THEY MANUALLY REMOVED THE ANVIL AND THE PATIENT IS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 33 MM | FHM | ETHICON ENDO-SURGERY, LLC | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |