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 2020-02-12 for MYOSURE REACH HYSTEROSCOPIC TISSUE REMOVAL SYSTEM 10-401FC manufactured by Hologic, Inc..
[179272524]
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
[179272525]
It was reported that the customer was performing a diagnostic hysteroscopy procedure utilizing the myosure device to diagnose for a possible polypectomy. The procedure began with diagnostic hysteroscopy, upon entry pathology was noted. A myosure device was opened to perform tissue sampling, sampling occurred for 14 seconds when physician and staff noticed a high fluid deficit and slow collapsing of the cavity. The procedure was stopped at this point and the physician performed ultrasound on the patient, fluid was confirmed "in the belly". Patient was transferred to hospital for observation. Follow up with the physician indicated that there was no serious injury to the patient as a result of the fluid distension loss. No medical interventions were performed to prevent permanent injury or a serious decline in patient health. The physician did not confirm the presence of a uterine perforation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2020-00030 |
| MDR Report Key | 9701985 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-12 |
| Date of Report | 2020-01-29 |
| Date of Event | 2020-01-29 |
| Date Mfgr Received | 2020-01-29 |
| Device Manufacturer Date | 2019-11-07 |
| Date Added to Maude | 2020-02-12 |
| 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 HYSTEROSCOPIC TISSUE REMOVAL SYSTEM |
| Generic Name | UTERINE TISSUE REMOVAL SYSTEM |
| Product Code | HIH |
| Date Received | 2020-02-12 |
| Model Number | 10-401FC |
| Catalog Number | 10-401FC |
| Lot Number | 19L07RA |
| 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. Hospitalization; 2. Other | 2020-02-12 |