FDA Adverse Event
Injury
Summary report: N
SURGICAL FIBER
MDR report key: 1030177
·
Received April 8, 2008
Report
- Report Number
- 2914019-2008-00009
- Event Type
- Injury
- Date Received
- April 8, 2008
- Date of Event
- March 19, 2008
- Report Date
- April 15, 2008
- Manufacturer
- LUMENIS, LTD YOKNEAM
- Product Code
- GEX
- PMA / PMN Number
- K011703
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE FIBER WAS DISPOSED OF BY THE CUSTOMER AND WAS NOT AVAILABLE FOR EVAL. A DETERMINATION OF PROBABLE CAUSE BASED ON THE EVENT DESCRIPTION IS THAT THE FIBER BROKE DUE TO MISUSE WHEN THE FIBER BEND RADIUS OR TENSILE STRENGTH WAS EXCEEDED DURING SETUP OR WHILE REMOVING FIBER FROM PACKING. ADD'L INFO REGARDING PT OUTCOME HAS BEEN REQUESTED. WHEN FURTHER EVENT INFO BECOMES AVAILABLE, A F/U MDR WILL BE FILED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A URETEROSCOPY, THE FIBER TIP DISMANTLED IN THE URETER. A STENT WAS PLACED TO DILATE THE URETER IN ORDER TO PASS THE FIBER TIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SURGICAL FIBER | LASER FIBER DELIVERY DEVICE | GEX | LUMENIS, LTD YOKNEAM | 840-842 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |