FDA Adverse Event
Other
Summary report: N
12MM KII THRD OPTICAL ACCESS SYS
MDR report key: 1316650
·
Received February 17, 2009
Report
- Report Number
- 2027111-2009-00010
- Event Type
- Other
- Date Received
- February 17, 2009
- Date of Event
- January 26, 2009
- Report Date
- February 17, 2009
- 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
INVESTIGATION SUMMARY: INVESTIGATION OF THE RETURNED PRODUCT REVEALED THAT THE LOSS OF PERITONEUM WAS CAUSED BY TOWN AND DAMAGED SEALS. THIS CONDITION CAN BE CAUSED BY INSERTION OF ASYMMETRICAL OR ANGULAR INSTRUMENTS SUCH AS J-HOOKS OR CLIP APPLIERS. APPLIED'S PRODUCT INFORMATION SHEET RECOMMENDS THAT EXTRA CARE BE EXERCISED WHEN USING THESE TOOLS WHICH SHOULD BE CENTERED AXIALLY BEFORE ADVANCEMENT THROUGH THE TROCAR. THIS DOCUMENT REPRESENTS OUR INITIAL AND FINAL REPORT.
Description of Event or Problem · 1
"SEAL FAILED-STARTED LEAKING EXCESS CO2-UNABLE TO CONTINUE CASE SWITCHING TO VIEW PORT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 12MM KII THRD OPTICAL ACCESS SYS | KII | GCJ | APPLIED MEDICAL RESOURCES | C0R29 | 1076842 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |