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 2017-07-14 for MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM 10-401 manufactured by Hologic, Inc..
[80052507]
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. 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 number was not provided by the complainant. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[80052508]
It was reported the physician performed a myosure procedure for uterine tissue removal on (b)(6)2017 and the fluid deficit rose to 2000ml with normal saline. The physical completed the procedure, but reported "i may have put a defect in the patient's uterine wall". There was no perforation and no intervention was required. The patient was fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2017-00182 |
| MDR Report Key | 6714055 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-07-14 |
| Date of Report | 2017-06-16 |
| Date of Event | 2017-06-16 |
| Date Mfgr Received | 2017-06-16 |
| Date Added to Maude | 2017-07-14 |
| 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 | MS. SIDRA PIRACHA |
| Manufacturer Street | 250 CAMPUS DRIVE |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5082638884 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM |
| Generic Name | UTERINE TISSUE REMOVAL DEVICE |
| Product Code | HIH |
| Date Received | 2017-07-14 |
| Catalog Number | 10-401 |
| Lot Number | UNKNOWN |
| Operator | PHYSICIAN |
| 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 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-07-14 |