FDA Adverse Event
Summary report: N
12X100MM KII FIOS FIRST ENTRY ADV FIXATION SYSTEM
MDR report key: 2621328
·
Received June 5, 2012
Report
- Report Number
- 2027111-2012-00148
- Date Received
- June 5, 2012
- Date of Event
- May 21, 2012
- Report Date
- June 5, 2012
- Manufacturer
- APPLIED MEDICAL RESOURCES CORP.
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INCIDENT DEVICE ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION.
Description of Event or Problem · 1
LAPAROSCOPIC ANTERIOR RESECTION - "WITH THE TROCA IN PLACE, A JOHANN GRASPER WAS PASSED THROUGH THE TROCAR AFTER WHICH A PIECE OF BLACK PLASTIC WAS OBSERVED SITTING ON THE BOWEL. THIS WAS THEN RETRIEVED." PATIENT STATUS: FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 12X100MM KII FIOS FIRST ENTRY ADV FIXATION SYSTEM | NONE | GCJ | APPLIED MEDICAL RESOURCES CORP. | CFF73 | 1159532 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |