MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-06-25 for BARD UROLASE RIGHT ANGLE LASER FIBER 350000 manufactured by Trimedyne, Inc..
[19084223]
It was reported that during a laser procedure, the fiber tip burned out and the tip seperated fromthe fiber shaft. The event occurred on first thirty-second laser application at 60 watts. The tip was retreived using grasping forceps through the previously placed scope as described in the product labeling. No further complicaitons were reportedinvalid data - regarding single use labeling of device. Patient medical status prior to event: unknown. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: none or unknown. Results of evaluation: none or unknown. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: yes. Corrective actions: none or unknown. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 33467-1993-00004 |
| MDR Report Key | 6170 |
| Date Received | 1993-06-25 |
| Date of Report | 1993-05-24 |
| Date Facility Aware | 1993-05-21 |
| Report Date | 1993-05-24 |
| Date Reported to FDA | 1993-05-24 |
| Date Reported to Mfgr | 1993-05-21 |
| Date Added to Maude | 1993-08-10 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | UNKNOWN |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARD UROLASE RIGHT ANGLE LASER FIBER |
| Generic Name | LASER FIBER |
| Product Code | GDB |
| Date Received | 1993-06-25 |
| Catalog Number | 350000 |
| Lot Number | 7592 |
| ID Number | 021993050129 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 5860 |
| Manufacturer | TRIMEDYNE, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1993-06-25 |