MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-14 for MYOSURE REACH TISSUE REMOVAL DEVICE 10-401FC manufactured by Hologic, Inc..
[180761528]
Lot number of the disposable device not provided by the complainant, therefore the expiration date is not known. The device is not being returned therefore, a failure analysis of the complaint device cannot be completed. If additional relevant information is received or device evaluation completed, a supplemental medwatch will be filed. Lot number of the disposable device not provided by the complainant, therefore the manufacture date is not known. Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.
Patient Sequence No: 1, Text Type: N, H10
[180761529]
It was reported that a physician was attempting to perform a myosure procedure on a patient with two uteri when a perforation was created. A hologic representative was not present for the procedure on (b)(6) 2020, and were made aware verbally on 05 february 2020. It is unclear at this time what device caused the perforation. The physician sampled tissue with the myosure and sent the sample to pathology, the sample came back as colon tissue. The physician discontinued the myosure procedure at this point and sampled the uterine cavity using a pipelle. The pipelle specimen came back as cancerous. A general surgeon was called in to "put a few stitches in the uterine perforation", no other damage was noted. The hologic rep was not made aware of any bowel perforation. No additional information at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2020-00032 |
| MDR Report Key | 9711273 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-14 |
| Date of Report | 2020-02-05 |
| Date of Event | 2020-01-29 |
| Date Mfgr Received | 2020-02-05 |
| Date Added to Maude | 2020-02-14 |
| 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 | MR. DAVID RAMSAY |
| Manufacturer Street | 250 CAMPUS DRIVE |
| Manufacturer City | MARLBOROUGH, MA |
| Manufacturer Country | US |
| Manufacturer Phone | 2638713 |
| 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 | 2020-02-14 |
| Model Number | 10-401FC |
| Catalog Number | 10-401FC |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Other; 2. Required No Informationntervention | 2020-02-14 |