MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-02-06 for MYOSURE REACH TISSUE REMOVAL DEVICE 10-401FC manufactured by Hologic, Inc..
[178124665]
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
[178124666]
It was reported that during a myosure procedure, the myosure control unit went black and needed to be reset. When the myosure device was removed from the patient the physician observed a piece of the blade was missing. The fragment was estimated to be the size of a few grains of sand, which broke off in the cavity and could not be located. It was not possible to find the fragment in the cavity via hysteroscopy. The physician notified pathology should the fragment be identified from the tissue trap. There was no injury to the patient reported at the time, no medical interventions were performed. Pathology confirmed that the metal fragment from the blade was found within the tissue trap.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2020-00026 |
| MDR Report Key | 9678555 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-02-06 |
| Date of Report | 2020-01-13 |
| Date of Event | 2020-01-13 |
| Date Mfgr Received | 2020-01-13 |
| Device Manufacturer Date | 2019-09-24 |
| Date Added to Maude | 2020-02-06 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR DAVID RAMSAY |
| Manufacturer Street | 250 CAMPUS DRIVE |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5082638713 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MYOSURE REACH TISSUE REMOVAL DEVICE |
| Generic Name | UTERINE TISSUE REMOVAL SYSTEM |
| Product Code | HIH |
| Date Received | 2020-02-06 |
| Returned To Mfg | 2020-02-22 |
| Model Number | 10-401FC |
| Catalog Number | 10-401FC |
| Lot Number | 19J24RB |
| 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 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-06 |