FDA Adverse Event
Summary report: N
GELPOINT SYSTEM, 100MM
MDR report key: 3030417
·
Received March 26, 2013
Report
- Report Number
- 2027111-2013-00104
- Date Received
- March 26, 2013
- Date of Event
- February 14, 2013
- Report Date
- March 26, 2013
- Manufacturer
- APPLIED MEDICAL
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT IS BEING RETURNED FOR EVALUATION AND NO LOT # HAS BEEN PROVIDED TO MANUFACTURER. A DEVICE HISTORY REPORT IS CURRENTLY REVIEWED BY ENGINEERING. A FINAL REPORT WILL BE SENT ONCE THE RESULTS HAVE BEEN ANALYZED.
Description of Event or Problem · 1
LAP. REVISION COLORECTAL ANASTAMOSIS: "WHILE REMOVING THE SPECIMEN, IT WAS DISCOVERED THAT THE WHITE CLEAR PORTION FROM INSIDE THE 12MM CANNULA HAD BEEN DISLODGE AND HAD FALLEN THRU THE 12MM CANNULA. THE DISLODGED PIECE THAT WAS COMPLETELY INTACT WAS FOUND ON THE OMENTUM."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 124943 | GELPOINT SYSTEM, 100MM | NONE | GCJ | APPLIED MEDICAL | CNGL2 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |