MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-10-26 for BARD UROLASE FIBER 350000 manufactured by Trimedyne, Inc..
[20759957]
It was reported that during a prostate ablation procedure, the fiber tip detached from the fiber shaft and remained in the pt's bladder. A prostatic uretheral irrigation washout was unsuccessful in removing the reported indwelling tip. The fiber tip is stillunaccounted for. No further complications were reported. Device labeled for single use. 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: device returned to manufacturer/dealer/distributor. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-1994-00010 |
| MDR Report Key | 9122 |
| Date Received | 1994-10-26 |
| Date of Report | 1994-09-26 |
| Date Facility Aware | 1994-09-21 |
| Report Date | 1994-09-26 |
| Date Reported to FDA | 1994-09-26 |
| Date Reported to Mfgr | 1994-09-26 |
| Date Added to Maude | 1994-11-30 |
| 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 FIBER |
| Generic Name | UROLASE FIBER |
| Product Code | GDB |
| Date Received | 1994-10-26 |
| Catalog Number | 350000 |
| Lot Number | 03BDT006 |
| ID Number | 021994090073 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | * |
| Implant Flag | * |
| Device Sequence No | 1 |
| Device Event Key | 8782 |
| Manufacturer | TRIMEDYNE, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-10-26 |