MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-17 for MYOSURE ROD LENS HYSTEROSCOPE 40-250 manufactured by Hologic, Inc.
[176867036]
Serial number of the disposable device not provided by the complainant, therefore the expiration date is not known. 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. Lot number of the 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 device as the identification numbers were not provided by the complainant.
Patient Sequence No: 1, Text Type: N, H10
[176867037]
It was reported that during the procedure, the surgeon performed a diagnostic hysteroscopy with the scope. "the physician stated that she did not have a clear view. The deficit rose quickly to the facility limit of 2500cc normal saline, at which time the hysteroscopy was aborted. " patient was brought back to the or several hours later for exam under anesthesia and possible laparoscopy. The hologic representative believes there was a suspected uterine perforation. No additional details available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2020-00014 |
| MDR Report Key | 9603454 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-17 |
| Date of Report | 2019-12-30 |
| Date of Event | 2019-12-30 |
| Date Mfgr Received | 2019-12-30 |
| Date Added to Maude | 2020-01-17 |
| 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 | KELSEA LYVER |
| Manufacturer Street | 250 CAMPUS DRIVE |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5082636130 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MYOSURE ROD LENS HYSTEROSCOPE |
| Generic Name | UTERINE HYSTEROSCOPE |
| Product Code | HIH |
| Date Received | 2020-01-17 |
| Model Number | 40-250 |
| Catalog Number | 40-250 |
| 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 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2020-01-17 |