FDA Adverse Event
Summary report: N
12X60MM KII OPITICAL ACCESS SYSTEM THREADED 6/BOX
MDR report key: 3030444
·
Received March 26, 2013
Report
- Report Number
- 2027111-2013-00100
- Date Received
- March 26, 2013
- Date of Event
- February 25, 2013
- Report Date
- March 26, 2013
- Manufacturer
- APPLIED MEDICAL
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RA HAS JUST RECEIVED THE INCIDENT DEVICE AND HAS BEEN ASSIGNED TO ENGINEERING FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF INVESTIGATION.
Description of Event or Problem · 1
LAPAROSCOPIC DISTAL GASTRECTOMY: "PROF (B)(6) FOUND A PIECE OF RUBBER INSIDE THE PATIENT'S ABDOMEN AT THE END OF THE PROCEDURE WHICH WAS LATER FOUND TO BE A PIECE OF THE SEAL TORN OFF FROM THE DEVICE. THE DEVICE WAS RETURN WITHOUT IT'S CANNULA OBTURATOR. THE SALES REP. CONFIRMED THAT A PIECE OF SEPTUM HAS BEEN TORN OFF FROM THE SEAL."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 123316 | 12X60MM KII OPITICAL ACCESS SYSTEM THREADED 6/BOX | NONE | GCJ | APPLIED MEDICAL | C0R83 | 1177216 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |