MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-27 for COVIDIEN SONICISION ULTRASONIC DISSECTOR 5MM-39 CM manufactured by Covidien Llc.
[29928828]
Jaw of sonicision cordless ultrasonic dissector broke off into the pt as surgeon was attempting to grab tissue to cauterize, the broken jaw landed on fatty tissue in pt's abdomen.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5057524 |
| MDR Report Key | 5187522 |
| Date Received | 2015-10-27 |
| Date of Report | 2015-10-12 |
| Date of Event | 2015-10-12 |
| Date Added to Maude | 2015-10-29 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | COVIDIEN SONICISION ULTRASONIC DISSECTOR 5MM-39 CM |
| Generic Name | SONICISION CORDLESS ULTRASONIC DISSECTOR |
| Product Code | REF |
| Date Received | 2015-10-27 |
| Lot Number | 255836X |
| Device Expiration Date | 2018-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LLC |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-10-27 |