MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-07-21 for STANDARD FOOTSWITCH E6008 manufactured by Covidien Lp.
[50129398]
(b)(4). Date of initial report: (b)(6) 2016. The incident sample has been requested but to date 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.
Patient Sequence No: 1, Text Type: N, H10
[50129399]
The customer reported that the coag pedal sticks in the "on" position. There was no patient/personnel injury associated with this failure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1717344-2016-00662 |
| MDR Report Key | 5813046 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-07-21 |
| Date of Report | 2016-06-27 |
| Date Mfgr Received | 2016-06-27 |
| Date Added to Maude | 2016-07-21 |
| 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 | MATTHEW AMARAL |
| Manufacturer Street | 5920 LONGBOW DR |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 2034926373 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STANDARD FOOTSWITCH |
| Generic Name | ES FOOTSWITCH |
| Product Code | BWA |
| Date Received | 2016-07-21 |
| Model Number | E6008 |
| Catalog Number | E6008 |
| Lot Number | 302734X |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-07-21 |