FDA Adverse Event
Other
Summary report: N
TROCAR DUAL PACKS 5MM
MDR report key: 1520520
·
Received October 28, 2009
Report
- Report Number
- 2027111-2009-00111
- Event Type
- Other
- Date Received
- October 28, 2009
- Date of Event
- September 13, 2009
- Report Date
- October 27, 2009
- Manufacturer
- APPLIED MEDICAL RESOURCES
- Product Code
- GCJ
- Report Source
- Manufacturer report
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
PRODUCT HAS NOT YET BEEN RETURNED FOR EVALUATION. A FOLLOW UP REPORT WILL BE ISSUED UPON COMPLETION OF INVESTIGATION.
Description of Event or Problem · 1
REPORTED (B)(6) 2009 TO APPLIED AUSTRALIA; REPORTED TO APPLIED US (B)(6) 2009. "PORTS BEING USED FOR LAP PROCEDURE RETRIEVAL OF APPENDIX OUT OF THE PORT. SURGEON NOTICED A BLACK SEGMENT WAS ON THE TV SCREEN. VALVE ON PORT BROKE THROUGH PROCEDURE. SURGEON NOTICED LOST SEAL WHEN INSTRUMENT REMOVED FROM PORT. SPECIMEN JAR WITH FAULTY PRODUCT RETURNED - CANNULA DETACHED AND NOT RETURNED. SURGEON (DR. LIZ WHAN) PLACED ANOTHER LAP FORCEP DOWN THE PORT TO RETRIEVE FOREIGN OBJECT FROM THE PT ABDOMEN AND WAS SUCCESSFUL."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TROCAR DUAL PACKS 5MM | NONE | GCJ | APPLIED MEDICAL RESOURCES | C0548 | 1090391 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |