FDA Adverse Event
Other
Summary report: N
15X100MM KII OPTICAL ACCESS SYSTEM NON-THREADED
MDR report key: 2222751
·
Received July 26, 2011
Report
- Report Number
- 2027111-2011-00075
- Event Type
- Other
- Date Received
- July 26, 2011
- Date of Event
- June 11, 2011
- Report Date
- July 19, 2011
- Manufacturer
- APPLIED MEDICAL
- 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 F/U REPORT WILL BE PROVIDED WITHIN 30 DAYS OR UPON COMPLETION OF INVESTIGATION. ADDITIONAL LOT NUMBER: 1120812.
Description of Event or Problem · 1
INCIDENT AS REPORTED; GASTRIC BANDING - "GASTRIC BAND WAS PASSED INTO THE PT'S ABDOMEN THROUGH THE C0R38 SEAL AND CANNULA. THE BLACK COMPONENT OF THE SEAL WAS THEN SEEN IN THE PT'S ABDOMEN. A FINGER WAS INSERTED INTO THE SEAL HOUSING OF CR38 AND THE CLEAR COMPONENT OF THE SEAL ALSO ENTERED THE PT'S ABDOMEN. TYPE OF INTERVENTION: COR38 WAS REMOVED AND REPLACED WITH ANOTHER COR38. APPROX 20 MINS WAS SPENT SEARCHING FOR AND RETRIEVING THE SEAL COMPONENTS. IN TOTAL, THE DELAY WAS ESTIMATED TO BE 45 MINUTES. NURSE UNSURE IF ALL SEAL COMPONENT WERE RETRIEVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 15X100MM KII OPTICAL ACCESS SYSTEM NON-THREADED | NONE | GCJ | APPLIED MEDICAL | C0R38 | 1125735 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |