MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-02-24 for LASERSONICS 1000 M BARE CHAMFER 0016-8433-01 manufactured by Surgimedics.
[9589]
Dr was using the laser fiber during an endometrial ablation and the tip of the fiber broke off. He was able to pull tip out of uterus with a small forceps.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1000856 |
| MDR Report Key | 11714 |
| Date Received | 1994-02-24 |
| Date of Report | 1994-01-28 |
| Date of Event | 1994-01-28 |
| Date Added to Maude | 1994-02-25 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LASERSONICS 1000 M BARE CHAMFER |
| Product Code | HHR |
| Date Received | 1994-02-24 |
| Catalog Number | 0016-8433-01 |
| Lot Number | 107131 |
| ID Number | MFR DATE: 5/30/91 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 11714 |
| Manufacturer | SURGIMEDICS |
| Manufacturer Address | THE WOODLANDS TX 77381 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-02-24 |