MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-03 for MYOSURE REACH HYSTEROSCOPIC TISSUE REMOVAL SYSTEM 10-401FC manufactured by Hologic, Inc.
[182163743]
The device has not yet been returned therefore, a failure analysis of the complaint device cannot be completed. If the device is returned and evaluation completed, a supplemental medwatch will be filed device history record (dhr) review was conducted for the reported identification number. The lot was released meeting all qa specifications.
Patient Sequence No: 1, Text Type: N, H10
[182163744]
It was reported that the blade was missing in the device. The doctor discovered this during the procedure as the device was making a strange noise. She depressed the foot pedal multiple times to check for the blade outside of the patient but it was not found. Attempts to gather additional information have been unsuccessful at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2020-00042 |
| MDR Report Key | 9781593 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-03 |
| Date of Report | 2020-02-11 |
| Date of Event | 2020-02-11 |
| Date Mfgr Received | 2020-02-11 |
| Device Manufacturer Date | 2019-11-11 |
| Date Added to Maude | 2020-03-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KELSEA LYVER |
| Manufacturer Street | 250 CAMPUS DRIVE |
| Manufacturer City | MARLBOROUGH, MA |
| Manufacturer Country | US |
| Manufacturer Phone | 2636130 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MYOSURE REACH HYSTEROSCOPIC TISSUE REMOVAL SYSTEM |
| Generic Name | UTERINE TISSUE REMOVAL SYSTEM, |
| Product Code | HIH |
| Date Received | 2020-03-03 |
| Returned To Mfg | 2020-03-04 |
| Model Number | 10-401FC |
| Catalog Number | 10-401FC |
| Lot Number | 19L11RJ |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC |
| Manufacturer Address | 250 CAMPUS DRIVE MARLBOROUGH, MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-03 |