FDA Adverse Event
Other
Summary report: N
15X100MM KII THREADED OPTICAL SEP ACCESS SYSTEM
MDR report key: 1635510
·
Received March 17, 2010
Report
- Report Number
- 2027111-2010-00039
- Event Type
- Other
- Date Received
- March 17, 2010
- Date of Event
- March 10, 2010
- Report Date
- March 16, 2010
- Manufacturer
- APPLIED MEDICAL RESOURCES
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT IS ANTICIPATED TO RETURN FOR EVAL. A FINAL REPORT WILL BE ISSUED UPON COMPLETION OF EVAL.
Description of Event or Problem · 1
LAP BAND - "THIS IS WHAT WAS TOLD TO ME BY THE OR TEAM LEADER, DR.(B)(6) WAS INSERTING A COVIDIEN STANDARD SIZE LAP BAND DOWN THROUGH THE 15MM TROCAR. AS THEY WERE GETTING NEAR THE END OF THE CASE, THEY NOTICED A SMALL BLACK PIECE OF SOMETHING IN THE PT. THEY REMOVED THE PIECE AND SAVE IT FOR ME. IT LOOKS LIKE A PIECE OF THE RUBBER SEAL. WE WILL SEND IT BACK FOR EVAL."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 15X100MM KII THREADED OPTICAL SEP ACCESS SYSTEM | NONE | GCJ | APPLIED MEDICAL RESOURCES | C0R37 | 1105453 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |