FDA Adverse Event
Summary report: N
12X150MM KII OPTICAL ACCESS SYSTEM THREADED
MDR report key: 2222830
·
Received August 2, 2011
Report
- Report Number
- 2027111-2011-00082
- Date Received
- August 2, 2011
- Date of Event
- June 24, 2011
- Report Date
- August 2, 2011
- Manufacturer
- APPLIED MEDICAL
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS INCIDENT WAS NOT REPORTED TO APPLIED MEDICAL. WE RECEIVED (B)(4) REPORT AND HAVE CONTACTED THE HOSP TO REQUEST THE RETURN OF THE EVENT SAMPLE FOR OUR INVESTIGATION. A F/U REPORT WILL BE SENT UPON COMPLETION OF THE EVAL.
Description of Event or Problem · 1
INCIDENT AS REPORTED: "TROCAR AS PLACED AND FUNCTIONING AT FIRST THEN DURING PROCEDURE, STAFF NOTED IT WAS LOSING THE PNEUMOPERITONEUM AND ATTEMPTED TO PUMP IN MORE GAS THAT WAS NOT EFFECTIVE. TROCAR REMOVED AND STAFF NOTED IT TO BE CRACKED. PROCEDURE COMPLETED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 12X150MM KII OPTICAL ACCESS SYSTEM THREADED | NONE | GCJ | APPLIED MEDICAL | C0R31 | 1122694 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |