FDA Adverse Event
Malfunction
Summary report: N
ANGLED DELIVERY DEVICE, GREENLIGHT
MDR report key: 2608247
·
Received June 5, 2012
Report
- Report Number
- 2937094-2012-00531
- Event Type
- Malfunction
- Date Received
- June 5, 2012
- Date of Event
- May 10, 2012
- Report Date
- May 11, 2012
- Manufacturer
- AMS INNOVATIVE CENTER-SAN JOSE
- Product Code
- GEX
- PMA / PMN Number
- K062719
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT DURING PROSTATE VAPORIZATION THE LASER BEAM EMITTED THROUGH A HOLE/CRACK NEXT TO THE OUTPUT WINDOW AT 118,799 JOULES. IT WAS REPORTED THAT THE PHYSICIAN IMMEDIATELY STOPPED WHEN THIS EVENT OCCURRED AND THAT THERE WAS NO PT INJURY. THE PROCEDURE WAS COMPLETED WITH A SECOND FIBER. THE PT OUTCOME WAS REPORTED AS "GOOD".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANGLED DELIVERY DEVICE, GREENLIGHT | SURGICAL FIBER | GEX | AMS INNOVATIVE CENTER-SAN JOSE | 0010-2090 | 104H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | GREENLIGHT SURGICAL LASER SYSTEM & ACCESSORIES |