MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2006-05-12 for VAPORMAX - HO:YAG SIDE FIRING HANDPIECE 20442-SMA manufactured by Trimedyne, Inc..
[471324]
The distal shaft snapped at the butterfly junction without apparent cause approximately ten minutes into procedure.
Patient Sequence No: 1, Text Type: D, B5
[7783200]
Analysis: to duplicate the reported event, the peek tubing was bent more than 45 degrees. The first precaution listed in the instructions for use states that the product should not be subjected to severe angle bends, drops, or excessive force, which may result in breaks or fractures. It appears that the fiber break was due to user error. Probable cause: fiber subjected to severe angle bends.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1419951-2006-00003 |
| MDR Report Key | 714637 |
| Report Source | 08 |
| Date Received | 2006-05-12 |
| Date of Report | 2006-05-11 |
| Date of Event | 2006-04-18 |
| Date Mfgr Received | 2006-04-18 |
| Device Manufacturer Date | 2006-04-01 |
| Date Added to Maude | 2006-05-17 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | GLENN YEIK, PRESIDENT |
| Manufacturer Street | 15091 BAKE PARKWAY |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9499513800 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VAPORMAX - HO:YAG SIDE FIRING HANDPIECE |
| Generic Name | LASER FIBER |
| Product Code | LLO |
| Date Received | 2006-05-12 |
| Model Number | 20442-SMA |
| Catalog Number | 20442-SMA |
| Lot Number | 601085 |
| ID Number | NA |
| Device Expiration Date | 2010-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 703702 |
| Manufacturer | TRIMEDYNE, INC. |
| Manufacturer Address | 15091 BAKE PKWY. IRVINE CA 92618 US |
| Baseline Brand Name | VAPROMAX HO:YAG SIDE FIRING HANDPIECE |
| Baseline Generic Name | LASER FIBER |
| Baseline Model No | 20442-SMA |
| Baseline Catalog No | 20442-SMA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-05-12 |