FDA Adverse Event
Summary report: N
EPIX LAPAROSCOPIC GRASPER, 5MM X 35CM
MDR report key: 3020574
·
Received March 20, 2013
Report
- Report Number
- 2027111-2013-00081
- Date Received
- March 20, 2013
- Date of Event
- February 28, 2013
- Report Date
- March 20, 2013
- Manufacturer
- APPLIED MEDICAL
- Product Code
- GCJ
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INCIDENT DEVICE ANTICIPATED TO RETURN. A F/U REPORT WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFO, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.
Description of Event or Problem · 1
GASTRIC BYPASS: "WHILE HANDLING THE BOWEL DURING A GASTRIC BYPASS PROCEDURE THE GRASPER CAUSED SEVERAL HOLE TEARS IN THE BOWEL. PLEASE NOTE THIS IS A SEPARATE INCIDENT TO THE ONE PREVIOUSLY REPORTED. SURGEON INVOLVED WAS (B)(6)." PT STATUS: "OK". INTERVENTION: "THE SURGEON HAS TO CLOSE THE 6 TO 8 TEAR WITH SUTURES."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 116460 | EPIX LAPAROSCOPIC GRASPER, 5MM X 35CM | NONE | GCJ | APPLIED MEDICAL | C4130 | 1173153 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |