MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07,company representative, report with the FDA on 2014-10-09 for GENERATOR PULSAR REFURBISHED PS100-100RF manufactured by Medtronic Advanced Energy, Llc.
[4783525]
Case #1 surgeon reports reversed activation on the pulsar i generator. When cut is pressed, display screen on generator show that coag mode is active. When coag is pressed, display screen on generator show that cut mode is active. Surgeon completed the case by pressing opposite button on hand piece to achieve desired effect. Patient information is unavailable as facility staff does not recall which case the issue occurred in. The surgeon using the generator is a new user of the product. Sales representative clarified that this may have been a customer confusion issue.
Patient Sequence No: 1, Text Type: D, B5
[12319852]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[35155447]
Product analysis # (b)(4). Complaint not confirmed lhr/dhr review: no associated manufacturing or servicing issues. Evaluation process: unit received in standard shipping container. Unit received in fair condition with minor surface imperfections. Power cord and user manual were received with unit. No handpieces were received. Internal visual inspection found nothing moving or broken in unit. Unit delivered rf energy correctly into fixed resistors. Root cause: the reported condition could not be replicated by the service department. Cut energy was keyed successfully by both handpiece switch and foot pedal: as was coag energy. Note that, when keying energy on the pulsar, the half of the screen for the activated power mode (either cut or coag) takes on a slightly dark hue while the other half of the screen takes on a much lighter hue (the intent was to make the unused mode appear to? Grey out?. ) this has led to confusion in the past because users have thought that, due to the more significant color change, the opposite power mode was being keyed.
Patient Sequence No: 1, Text Type: N, H10
[35155448]
Surgeon reports reversed activation on the pulsar i generator. When cut is pressed, display screen on generator show that coag mode is active. When coag is pressed, display screen on generator show that cut mode is active. Surgeon completed the case by pressing opposite button on hand piece to achieve desired effect. Patient information is unavailable as facility staff does not recall which case the issue occurred in. The surgeon using the generator is a new user of the product. Sales representative clarified that this may have been a customer confusion issue.
Patient Sequence No: 1, Text Type: D, B5
[103813432]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226420-2014-00099 |
| MDR Report Key | 4154842 |
| Report Source | 06,07,COMPANY REPRESENTATIVE, |
| Date Received | 2014-10-09 |
| Date of Report | 2014-12-03 |
| Date of Event | 2014-09-10 |
| Date Mfgr Received | 2014-12-03 |
| Date Added to Maude | 2014-10-22 |
| 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 | KAYLEE BOISVERT |
| Manufacturer Street | 180 INTERNATIONAL DRIVE |
| Manufacturer City | PORTSMOUTH NH 03801 |
| Manufacturer Country | US |
| Manufacturer Postal | 03801 |
| Manufacturer Phone | 6038426234 |
| Manufacturer G1 | MEDTRONIC ADVANCED ENERGY, LLC |
| Manufacturer Street | 180 INTERNATIONAL DRIVE |
| Manufacturer City | PORTSMOUTH NH 03801 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 03801 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GENERATOR PULSAR REFURBISHED |
| Generic Name | GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER |
| Product Code | MUL |
| Date Received | 2014-10-09 |
| Returned To Mfg | 2014-09-17 |
| Model Number | PS100-100RF |
| Catalog Number | PS100-100RF |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC ADVANCED ENERGY, LLC |
| Manufacturer Address | 180 INTERNATIONAL DRIVE PORTSMOUTH NH 03801 US 03801 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-10-09 |