FDA Adverse Event
Summary report: N
12X100MM KII GELPORT BALLOON TROCAR SYSTEM
MDR report key: 2222791
·
Received August 1, 2011
Report
- Report Number
- 2027111-2011-00078
- Date Received
- August 1, 2011
- Date of Event
- July 8, 2011
- Report Date
- July 25, 2011
- Manufacturer
- APPLIED MEDICAL
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INCIDENT IS BEING REPORTED DUE TO RECEIPT OF A MEDWATCH REPORT, NO INDICATION OF INJURY OR INTERVENTION. THE INCIDENT DEVICE ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED WITHIN 30 DAYS OR UPON COMPLETION OF INVESTIGATION.
Description of Event or Problem · 1
LAP CHOLE - "AFTER INCISION WAS MADE, PHYSICIAN WENT TO UTILIZE THE TROCAR AND PART OF THE BALLOON PEELED OFF. A SECOND TROCAR WAS OPENED TO COMPLETE PROCEDURE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 12X100MM KII GELPORT BALLOON TROCAR SYSTEM | NONE | GCJ | APPLIED MEDICAL | C0R47 | 1138201 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |