FDA Adverse Event
Malfunction
Summary report: N
ANGLED DELIVERY DEVICE, GREENLIGHT
MDR report key: 2479199
·
Received February 24, 2012
Report
- Report Number
- 2937094-2012-00162
- Event Type
- Malfunction
- Date Received
- February 24, 2012
- Date of Event
- August 13, 2011
- Report Date
- February 2, 2012
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC.
- Product Code
- GEX
- PMA / PMN Number
- K062719
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4) - REFERS TO FORWARD-FIRING OF THE SIDE-FIRING SURGICAL FIBER; A CODE REQUEST HAS BEEN SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE USING A SIDE-FIRING FIBER FOR PROSTATE VAPORIZATION, THE AIM BEAM WAS OBSERVED TO BE FORWARD-FIRING INTO THE PATIENT'S BLADDER. THE FORWARD-FIRING CONDITION WAS OBSERVED WHEN THE FIBER HAD ACCUMULATED 29,917 JOULES. THE PROCEDURE WAS CONTINUED WITH A SECOND FIBER (REFERENCE MFR REPORT NUMBER 2937094-2012-00171) AND COMPLETED WITH A THIRD FIBER. NEITHER THE PATIENT NOR THE END USER EXPERIENCED ANY INJURIES AS A RESULT OF THIS EVENT. THE PATIENT OUTCOME WAS REPORTED AS THE PATIENT WAS "DOING WELL."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANGLED DELIVERY DEVICE, GREENLIGHT | SURGICAL FIBER | GEX | AMERICAN MEDICAL SYSTEMS, INC. | 0010-2090 | 105H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | GREENLIGHT SURGICAL LASER SYSTEM| ACCESSORIES |