MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-05-17 for FORCETRIAD ENERGY PLATFORM manufactured by Covidien Lp.
[45332845]
(b)(4). To date the unit has not been received for evaluation. If the sample is received or if additional information pertinent to the incident is obtained a follow-up report will be submitted. A review of the device history records indicated that this serial number was released meeting all specifications as manufactured.
Patient Sequence No: 1, Text Type: N, H10
[45332846]
The customer reported that during a total lap hysterectomy the forcetriad failed to generate an electrical current through monopolar and ligasure ports resulting in patient bleeding. The bleeding was controlled and the patient received 2 units of blood through transfusion.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1717344-2016-00409 |
| MDR Report Key | 5659953 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-05-17 |
| Date of Report | 2016-04-21 |
| Date of Event | 2016-04-08 |
| Date Mfgr Received | 2016-05-12 |
| Device Manufacturer Date | 2012-04-30 |
| Date Added to Maude | 2016-05-17 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SHARON MURPHY |
| Manufacturer Street | 5920 LONGBOW DRIVE |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 2034925267 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FORCETRIAD ENERGY PLATFORM |
| Generic Name | ELECTROSURGICAL GENERATOR |
| Product Code | BWA |
| Date Received | 2016-05-17 |
| Catalog Number | FORCETRIAD |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LP |
| Manufacturer Address | 5920 LONGBOW DRIVE BOULDER CO 80301 US 80301 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-05-17 |