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 2016-08-29 for FOOTSWITCH E6009 manufactured by Covidien Lp.
[53385044]
(b)(4). Date of initial report: (b)(6) 2016. To date, the incident sample 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
[53385045]
The customer reported that while the doctor was using the foot pedal, the pedal became stuck in the on position. There was no patient present.
Patient Sequence No: 1, Text Type: D, B5
[58488970]
Covidien reference#: (b)(4). Date of initial report: 08/29/2016. Date of follow-up report: 10/26/2016. Evaluation of the incident device found it to function normally and within specifications. No conditions were identified that would have caused or contributed to the reported event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1717344-2016-00803 |
| MDR Report Key | 5910770 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2016-08-29 |
| Date of Report | 2016-08-01 |
| Date of Event | 2016-08-01 |
| Date Mfgr Received | 2016-10-25 |
| Date Added to Maude | 2016-08-29 |
| 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 | 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 | FOOTSWITCH |
| Generic Name | ES ACCESSORY |
| Product Code | BWA |
| Date Received | 2016-08-29 |
| Returned To Mfg | 2016-08-26 |
| Model Number | E6009 |
| Catalog Number | E6009 |
| Lot Number | 289139X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-08-29 |