MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-03-31 for SONICISION SCD391 manufactured by Covidien Mfg Dc Boulder.
[186104367]
(b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[186104368]
According to the reporter, intra-operatively, one side of the jaw of the instrument broke off within the patient's abdomen, but was retrieved. The patient was reported to have fatal consequences.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1717344-2020-00363 |
| MDR Report Key | 9902470 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-11 |
| Device Manufacturer Date | 2019-07-01 |
| Date Added to Maude | 2020-03-31 |
| 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 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 | 2020-03-31 |
| Model Number | SCD391 |
| Catalog Number | SCD391 |
| Lot Number | 91780028X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 1. Other | 2020-03-31 |