MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-10-05 for BARD UROLASE RIGHT ANGLE LASER FIBER UNKNOWN 350000 manufactured by Trimedyne, Inc..
[623]
It was reported that during a lasing procedure, the fiber tip burned out and seperated from the fiber shaft. Biospy forceps were inserted through the previously placed scope and the tip was retrieved as described in the product labeling. No patient injury or further complications 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 not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: unknown (cannot determine). Corrective actions: none or unknown. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-1992-00001 |
| MDR Report Key | 1515 |
| Date Received | 1992-10-05 |
| Date of Report | 1992-09-25 |
| Date of Event | 1992-09-16 |
| Date Facility Aware | 1992-09-16 |
| Report Date | 1992-09-25 |
| Date Reported to FDA | 1992-09-25 |
| Date Reported to Mfgr | 1992-09-16 |
| Date Added to Maude | 1992-10-22 |
| 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 | LWX |
| Date Received | 1992-10-05 |
| Model Number | UNKNOWN |
| Catalog Number | 350000 |
| Lot Number | 7231 |
| ID Number | 021992090258 |
| Operator | OTHER |
| Device Availability | * |
| Implant Flag | * |
| Device Sequence No | 1 |
| Device Event Key | 1448 |
| Manufacturer | TRIMEDYNE, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1992-10-05 |