MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-18 for MYOSURE TISSUE REMOVAL SYSTEMCONTROL UNIT 10-550 manufactured by Hologic, Inc..
[179762549]
At the tail end of procedure, the myosure device stopped working and could not be restarted. Yearly calibration was completed. Device sequestered after procedure, inspected and returned to manufacturer. A replacement unit has been received. No harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9720443 |
| MDR Report Key | 9720443 |
| Date Received | 2020-02-18 |
| Date of Report | 2020-02-03 |
| Date of Event | 2020-01-30 |
| Report Date | 2020-02-03 |
| Date Reported to FDA | 2020-02-03 |
| Date Reported to Mfgr | 2020-02-18 |
| Date Added to Maude | 2020-02-18 |
| 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 | RISK MANAGER |
| 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 SYSTEMCONTROL UNIT |
| Generic Name | HYSTEROSCOPE (AND ACCESSORIES) |
| Product Code | HIH |
| Date Received | 2020-02-18 |
| Returned To Mfg | 2020-02-14 |
| Model Number | 10-550 |
| Catalog Number | 10-550 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC. |
| Manufacturer Address | 250 CAMPUS DR MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-18 |