MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-25 for MYOSURE TISSUE REMOVAL DEVICE 50-501XL manufactured by Hologic, Inc..
[184875288]
Device worked and cut fine for about 4 minutes. Dr. Said was resecting a large uterine fibroid. Device blade either dulled or device suction got clogged. New device (myosure reach) was opened to complete the procedure safely. Rep will call device into company technical support and send back for device evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9876860 |
| MDR Report Key | 9876860 |
| Date Received | 2020-03-25 |
| Date of Report | 2020-02-24 |
| Date of Event | 2019-08-28 |
| Report Date | 2020-02-24 |
| Date Reported to FDA | 2020-02-24 |
| Date Reported to Mfgr | 2020-03-25 |
| Date Added to Maude | 2020-03-25 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MYOSURE TISSUE REMOVAL DEVICE |
| Generic Name | HYSTEROSCOPE (AND ACCESSORIES) |
| Product Code | HIH |
| Date Received | 2020-03-25 |
| Returned To Mfg | 2019-09-05 |
| Model Number | 50-501XL |
| Catalog Number | 50-501XL |
| Lot Number | 18K30RA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC. |
| Manufacturer Address | 445 SIMARANO DRIVE MARLBORO MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-25 |