FDA Adverse Event
Other
Summary report: N
KII OPTICAL ACCESS 11MM
MDR report key: 1182390
·
Received September 30, 2008
Report
- Report Number
- 2027111-2008-00049
- Event Type
- Other
- Date Received
- September 30, 2008
- Date of Event
- September 1, 2008
- Report Date
- September 30, 2008
- Manufacturer
- APPLIED MEDICAL RESOURCES
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INCIDENT DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. UPON RETURN AND EVALUATION, A FOLLOW-UP REPORT WILL BE GENERATED AND SUBMITTED.
Description of Event or Problem · 1
"DR. WAS USING PRODUCT FOR LAP CHOLE. FIRST CASE WITH NEW KII PRODUCT. SMALL PIECE OF DUCKBILL SEAL APPEARS TO HAVE FRAGMENTED. DR. REMOVED LAPAROSCOPICALLY FROM PATIENT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KII OPTICAL ACCESS 11MM | NONE | GCJ | APPLIED MEDICAL RESOURCES | C0R21 | 1067034 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |