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 2020-02-03 for HYSTEROSCOPIC FLUID MANAGEMENT 7210164 manufactured by Covidien Mansfield.
[177587627]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[177587628]
According to the reporter, during hysteroscopic resection while inside the uterine cavity during myometrial penetration, the surgeon noticed an increased in the fluid deficit level. Surgeon said the deficit was 1000cc at one point. After 5 minutes, deficit was 5000cc. Surgeon said there were no alarms or beeps. Machine was checked later and found to have proper fluid deficit alarming function. It was suggested by surgeon to increased volume of alarm. Nurse did not communicate nor report the deficit during this 5 minutes interval. Patient was given lasix intravenously. Surgeon said patient urine was 4000cc following lasix. There was no change in patient electrolytes and was discharged. All tissue had been resected. Procedure was completed. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1282497-2020-00006 |
| MDR Report Key | 9660647 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-03 |
| Date of Report | 2020-02-03 |
| Date of Event | 2020-01-08 |
| Date Mfgr Received | 2020-01-21 |
| Date Added to Maude | 2020-02-03 |
| 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 | LISA HERNANDEZ |
| Manufacturer Street | 5920 LONGBOW DRIVE |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 2034925563 |
| Manufacturer G1 | COVIDIEN MANSFIELD |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02048 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYSTEROSCOPIC FLUID MANAGEMENT |
| Generic Name | INSUFFLATOR, HYSTEROSCOPIC |
| Product Code | HIG |
| Date Received | 2020-02-03 |
| Model Number | 7210164 |
| Catalog Number | 7210164 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN MANSFIELD |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-03 |