FDA Adverse Event
Summary report: N
12X60MM KII OPITCAL ACCESS SYSTEM THREADED 6/BOX
MDR report key: 2833788
·
Received November 5, 2012
Report
- Report Number
- 2027111-2012-00339
- Date Received
- November 5, 2012
- Date of Event
- October 16, 2012
- Report Date
- November 6, 2012
- Manufacturer
- APPLIED MEDICAL
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- 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. IN ACCORDANCE TO 21 CFR 803-56, IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.
Description of Event or Problem · 1
SINGLE PORT CHOLECTOMY - "DURING THE PROCEDURE, (B)(6) FOUND A PIECE OF RUBBER INSIDE THE PT'S ABDOMINAL CAVITY WHICH LATER FOUND TO BE A PIECE TORN OFF FROM THE INNER SEPTUM OF THE SEAL."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 12X60MM KII OPITCAL ACCESS SYSTEM THREADED 6/BOX | NONE | GCJ | APPLIED MEDICAL | C0R83 | 1163314 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |