MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-26 for SONICISION SCDA39 manufactured by Covidien Mfg Dc Boulder.
[185219944]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185219945]
According to the reporter, intra-operatively, the device broken off and it is in a separate container. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
[188677942]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188677963]
According to the reporter, intra-operatively, the device broken off outside the patients cavity and it is in separate container. They used another like device to complete the procedure. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1717344-2020-00343 |
MDR Report Key | 9882717 |
Report Source | COMPANY REPRESENTATIVE,FOREIG |
Date Received | 2020-03-26 |
Date of Report | 2020-04-01 |
Date of Event | 2020-03-09 |
Date Mfgr Received | 2020-03-12 |
Device Manufacturer Date | 2019-04-22 |
Date Added to Maude | 2020-03-26 |
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 |
Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
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 MFG DC BOULDER |
Manufacturer Street | 5920 LONGBOW DR |
Manufacturer City | BOULDER CO 803013299 |
Manufacturer Country | US |
Manufacturer Postal Code | 803013299 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | SONICISION |
Generic Name | INSTRUMENT, ULTRASONIC SURGICAL |
Product Code | LFL |
Date Received | 2020-03-26 |
Returned To Mfg | 2020-03-13 |
Model Number | SCDA39 |
Catalog Number | SCDA39 |
Lot Number | 91010053X |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Age | DA |
Device Eval'ed by Mfgr | N |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | COVIDIEN MFG DC BOULDER |
Manufacturer Address | 5920 LONGBOW DR BOULDER CO 803013299 US 803013299 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2020-03-26 |