FDA Adverse Event
Malfunction
Summary report: N
GCJ LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
MDR report key: 1455310
·
Received May 1, 2009
Report
- Report Number
- 3005075853-2009-02624
- Event Type
- Malfunction
- Date Received
- May 1, 2009
- Date of Event
- April 7, 2009
- Report Date
- April 7, 2009
- Manufacturer
- ETHICON ENDO-SURGERY, LLC
- Product Code
- GCJ
- PMA / PMN Number
- K070198
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE SENT: 5/1/2009. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A HAND ASSISTED COLON RESECTION PROCEDURE THE DEVICE WAS TORN WHEN THE DEVICE WAS OPENED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GCJ LAPAROSCOPE, GENERAL AND PLASTIC SURGERY | GCJ | ETHICON ENDO-SURGERY, LLC | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |