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 2020-02-18 for MYOSURE ROD LENS HYSTEROSCOPE W/ REMOVABLE OUTFLOW CHANNEL 40-250 manufactured by Hologic, Inc..
[180761919]
Serial number of the reusable device not provided by the complainant. The device has not yet been returned therefore, a failure analysis of the complaint device cannot be completed. Serial number of the reusable 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 reusable device or the fluid management console as the identification numbers were not provided by the complainant. If the device is returned and evaluation completed, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[180761920]
It was reported that during a procedure involving a myosure hysteroscope the physician had suspected a uterine perforation based on the fluid deficit readings on the fluent fluid management console. The fluid was observed to flow into the patient cavity, however the fluid flow was not exiting the patient and the deficit was rising. The physician attempted to view the patient cavity to inspect and confirm the presence of a perforation, however the cavity was blocked and it was not possible to visualize the interior of the patient uterus. The physician was unable to confirm the perforation, but made the decision to abort the procedure. No additional details at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2020-00036 |
| MDR Report Key | 9720337 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-02-18 |
| Date of Report | 2020-02-03 |
| Date of Event | 2020-02-03 |
| Date Mfgr Received | 2020-02-03 |
| Date Added to Maude | 2020-02-18 |
| 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 ROD LENS HYSTEROSCOPE W/ REMOVABLE OUTFLOW CHANNEL |
| Generic Name | UTERINE HYSTEROSCOPE |
| Product Code | HIH |
| Date Received | 2020-02-18 |
| Model Number | 40-250 |
| Catalog Number | 40-250 |
| Lot Number | N/A |
| 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 | 2020-02-18 |