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 2020-02-14 for OMNI HYSTEROSCOPE STANDARD KIT 60-250-1 manufactured by Hologic, Inc..
[180760916]
Serial number of the reusable 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. 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 as the identification numbers were not provided by the complainant. If additional relevant information is received or device evaluation completed, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[180760917]
It was reported that during a procedure involving an omni scope device the physician was unable to insert the scope past the external os as the patient was stenotic. The physician dilated the patient again and was able to insert the omni scope. Right after insertion the physician believed they had perforated the uterus. The physician then inserted a myosure lite device and performed a quick sampling. The procedure ended, patient did not show any signs of fluid overload. The physician spoke with the anesthesiologist at the end of the case regarding the perforation and not treating it; the anesthesiologist thought the patient would be fine without further intervention. No additional information available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2020-00033 |
| MDR Report Key | 9711404 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-14 |
| Date of Report | 2020-01-31 |
| Date of Event | 2020-01-31 |
| Date Mfgr Received | 2020-01-31 |
| Date Added to Maude | 2020-02-14 |
| 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 | 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 | OMNI HYSTEROSCOPE STANDARD KIT |
| Generic Name | HYSTEROSCOPE |
| Product Code | HIH |
| Date Received | 2020-02-14 |
| Model Number | 60-250-1 |
| Catalog Number | 60-250-1 |
| 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 | 2020-02-14 |