MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-05-18 for BARD UROLASE RIGHT ANGLE LASER FIBER 350000 manufactured by Trimedyne, Inc..
[16480249]
It was reported that during a lasing procedure, the fiber tip burned a hole through the prostate and bladder wall. No additional medical or surgical intervention was performed as a result of the invent. The doctor will monitor the patient for 24 hours to 36 hours. There was no alleged failure of the device to perform its intended function. Acontinuous irrigation scope was used in conjunction with the laser fiberdevice labeled for single use. Patient medical status prior to event: invalid data. Invalid data - regarding 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. Invalid data - regarding whether event presents imminent hazard. Device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-1993-00003 |
| MDR Report Key | 6019 |
| Date Received | 1993-05-18 |
| Date of Report | 1993-04-15 |
| Date Facility Aware | 1993-04-13 |
| Report Date | 1993-04-15 |
| Date Reported to FDA | 1993-04-15 |
| Date Reported to Mfgr | 1993-04-14 |
| Date Added to Maude | 1993-08-02 |
| 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 | 1993-05-18 |
| Catalog Number | 350000 |
| Lot Number | UNKNOWN |
| ID Number | 021993040105 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 5714 |
| Manufacturer | TRIMEDYNE, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1993-05-18 |