MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-08-26 for LIGHTSTIC 360 DIFFUSER UNK manufactured by Rare Earth Medical Inc.
[259368]
This pt was being treated with photodynamic therapy (pdt) for esophageal cancer. Two separate devices (called the "lightstic 360 diffuser") were being used in the procedure, both of them made by cardiofocus, inc. According to mfr's literature, "this single-use-only fiberoptic device is intended to deliver laser energy to desired tissue. Delivery of the light is intended to photoactivate a drug contained in the targeted tissue as part of a pre-clinical photodynamic therapy procedure. " the tips (on the shaft portion) of both diffusers broke off during the endoscopic procedure. The tips that broke off of the primary devices were retrieved during or immediately following the surgery and were discarded. The remaining portions of both devices are being stored in the risk mgmt dept. By looking at the remaining portions of the two devices, the point where the breakage occurred on the shaft of each device appears blackened, as if burnt. The points of breakage on the two diffusers have the appearance of a blackened matchstick tip that had once been lighted. No complications resulted from this event, the surgery was not extended in any way and all device fragments were retrieved. Unfortunately, the broken-off tips, once retrieved, were discarded during or immediately following the surgery; however, the remaining portion of each of the two diffusers was preserved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1025976 |
| MDR Report Key | 413390 |
| Date Received | 2002-08-26 |
| Date of Report | 2002-08-19 |
| Date of Event | 2002-07-30 |
| Date Added to Maude | 2002-08-30 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIGHTSTIC 360 DIFFUSER |
| Generic Name | PHOTODYNAMIC THERAPY DIFFUSER |
| Product Code | LQJ |
| Date Received | 2002-08-26 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 402441 |
| Manufacturer | RARE EARTH MEDICAL INC |
| Manufacturer Address | 126B MID-TECH DR WEST YARMOUTH MA 02673 US |
| Brand Name | LIGHTSTIC 360 DIFFUSER |
| Generic Name | PHOTODYNAMIC THERAPY DIFFUSER |
| Product Code | LQJ |
| Date Received | 2002-08-26 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 2 |
| Device Event Key | 402443 |
| Manufacturer | RARE EARTH MEDICAL INC. |
| Manufacturer Address | 126B MID-TECH DR WEST YARMOUTH MA 02673 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-08-26 |