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 2017-10-12 for VALLEYLAB E6009 manufactured by Covidien Mfg Dc Boulder.
[89826938]
The incident sample was requested but to date has not been received for evaluation. If the sample or additional information pertinent to the incident is obtained, a follow-up report will be submitted. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[89826940]
The customer reported that the device was causing the generator to continuously activate. There is no patient injury associated with this issue.
Patient Sequence No: 1, Text Type: D, B5
[131833001]
Device evaluation one unit was returned for evaluation. The returned sample did not meet specification as received. A visual inspection found the device was missing a spring. The investigation confirmed the reported condition. The investigation found that the bipolar foot pedal was missing a spring which was causing a continuous activation on the bipolar foot pedal and lead to the issue with the other ports not activating. The investigation isolated the failure to the missing spring on the bipolar footswitch, but a root cause was not identified. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1717344-2017-06046 |
| MDR Report Key | 6945500 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2017-10-12 |
| Date of Report | 2017-11-21 |
| Date Mfgr Received | 2017-10-26 |
| Date Added to Maude | 2017-10-12 |
| 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 |
| 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 | VALLEYLAB |
| Generic Name | UNIT, ELECTROSURGICAL ANDCOAGULATION, WITH ACCESSORIES |
| Product Code | BWA |
| Date Received | 2017-10-12 |
| Model Number | E6009 |
| Catalog Number | E6009 |
| Lot Number | 243327X |
| Device Expiration Date | 1999-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-10-12 |