MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2008-07-18 for OMNI(TM) MULTIUSE HANDPIECE 20471-HP manufactured by Trimedyne, Inc..
[881610]
It was reported that during a knee arthroscopy procedure, "while running on holmium laser, handpiece caught on fire. There was a beam or output seen. The doctor did ask to turn up the rate to 3. 5 and that is when the handle piece started on fire. " reporter indicated that the area that melted was "black piece near where the tip connects to the handpiece. " reporter provided the following additional information: no patient, user or other person was injured. They were using both a reusable fiber (switchable tip) and a reusable handpiece/fiber assembly. Both devices had been used multiple times. No pre-testing of devices before use. At the end of the procedure a "spark" and "flame" were seen; they immediately removed the devices from the area and extinguished the fiber. This information is documented as reported to trimedyne.
Patient Sequence No: 1, Text Type: D, B5
[7885190]
No consequence or impact to patient.
Patient Sequence No: 1, Text Type: N, H10
[8213800]
The manufacturer completed all of the information on this form.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1419951-2008-00007 |
| MDR Report Key | 1077347 |
| Report Source | 06 |
| Date Received | 2008-07-18 |
| Date of Report | 2008-10-29 |
| Date of Event | 2008-06-18 |
| Date Mfgr Received | 2008-08-29 |
| Device Manufacturer Date | 2007-06-29 |
| Date Added to Maude | 2008-10-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | MR. GLENN YEIK |
| Manufacturer Street | 25901 COMMERCENTRE DRIVE |
| Manufacturer City | LAKE FOREST CA 926308805 |
| Manufacturer Country | US |
| Manufacturer Postal | 926308805 |
| Manufacturer Phone | 9499513800 |
| Manufacturer G1 | TRIMEDYNE, INC. |
| Manufacturer Street | 25901 COMMERCENTRE DRIVE |
| Manufacturer City | LAKE FOREST CA 92630880 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92630 8805 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OMNI(TM) MULTIUSE HANDPIECE |
| Generic Name | LASER FIBER |
| Product Code | RHL |
| Date Received | 2008-07-18 |
| Returned To Mfg | 2008-07-18 |
| Model Number | 20471-HP |
| Catalog Number | 20471-HP |
| Lot Number | 609046 |
| Device Expiration Date | 2010-07-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1044181 |
| Manufacturer | TRIMEDYNE, INC. |
| Manufacturer Address | 25901 COMMERCENTRE DRIVE LAKE FOREST CA 92630 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-07-18 |