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 2020-03-20 for MYOSURE ROD LENS HYSTEROSCOPE 40-250 manufactured by Hologic, Inc.
[184386650]
Serial number of the 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. Serial 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 disposable device as the identification numbers were not provided by the complainant.
Patient Sequence No: 1, Text Type: N, H10
[184386651]
It was reported that during the procedure, after dilating the patient and removing a vaginal septum, the physician inserted the scope "through the wrong entry and perforated where you could see the bowel. " a laparoscopy was performed to repair the tear. Additional information received from hologic representative makes it unclear if the perforation was in the vaginal canal or uterus. No additional details available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2020-00058 |
| MDR Report Key | 9862921 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-20 |
| Date of Report | 2020-02-27 |
| Date of Event | 2020-02-27 |
| Date Mfgr Received | 2020-02-27 |
| Date Added to Maude | 2020-03-20 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 2636130 |
| 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 | 2020-03-20 |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2020-03-20 |