FDA Adverse Event
Other
Summary report: N
23GA ENDO OCCULAR ADJUSTABLE LASER PROBE
MDR report key: 1762854
·
Received July 19, 2010
Report
- Report Number
- 2529392-2010-00001
- Event Type
- Other
- Date Received
- July 19, 2010
- Date of Event
- June 1, 2010
- Report Date
- June 21, 2010
- Manufacturer
- PEREGRINE SURGICAL LTD.
- Product Code
- GEX
- PMA / PMN Number
- K024061
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION CONCLUDED THAT DEVICE BREAKING WAS AN ISOLATED INCIDENCE. FIBER MOST LIKELY HAD A SLIGHT IMPERFECTION THAT INCREASED WITH USE AND ALLOWED LASER TO BURN THROUGH PROTECTIVE SHEATH. SURGEON MEETING RESISTANCE WHEN REMOVING PROBE CAUSED WEAKENED FIBER AND SHEATH TO BREAK.
Description of Event or Problem · 1
LASER PROBE USED FOR PHOTOCOAGULATION DURING OPHTHALMIC SURGERY. UPON COMPLETION OF THE LASER PORTION OF THE SURGERY, THE PROBE WAS BEING REMOVED FROM THE EYE WHEN THE SURGEON MET RESISTANCE AND THE FIBER AND PROTECTIVE SHEATH BROKE OFF. SURGERY TIME WAS EXTENDED TO RETRIEVE PIECE THAT BROKE OFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 23GA ENDO OCCULAR ADJUSTABLE LASER PROBE | 23GA ADJUSTABLE LASER PROBE | GEX | PEREGRINE SURGICAL LTD. | 920228 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |