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 2014-12-12 for GENERATOR PULSAR II PS100-102 manufactured by Medtronic Advanced Energy Llc.
[5134524]
A few minutes into the case, after the customer stopped depressing the coag button, the generator still showed as active and still gave the coag tone, however, the hand piece wasn? T active (there was no rf energy going to the hand piece). The generator was restarted and the issue was resolved. Approximately 10 minutes later, while being used on coag, the generator stopped showing as active, there was no activation tone and the screen did not indicated coag as active. This occurred although the customer was continuing to depress the coag button on the hand piece and the hand piece itself was still coagulating and still had rf energy going to it. The issue was resolved when the customer stopped depressing coag on the hand piece. Approximately 15 minutes later, after a subsequent activation on coag, when the customer stopped depressing the coag button, the generator still showed as active and still gave the coag tone, however the hand piece wasn? T active and there was no rf energy going to the hand piece. A different generator was brought in and used with the same hand piece to successfully complete the case. Cut was not affected.
Patient Sequence No: 1, Text Type: D, B5
[12739773]
(b)(4). Method, results, conclusion: product received by manufacturer and pending inspection. Product event: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[37877951]
(b)(4) evaluation process: performed visual inspection on unit per tcl-514-900008. -no issues found. Performed baseline functional testing pertcl-514-900008. -unit delivered correct levels of rf energy in all modes. Unit was tested over an extended period od time; keyed for 12 minutes at 6w low coag 1 (15s on, 15s off) and then for 12minutes at 50w high coag (15s on, 15s off) while being observed. The lcd was once observed to lock up with the lcd and speaker indicating that energy was being delivered despite the handpiece button being released and no energy being delivered to the handpiece. Later, the lcd was once observed suddenly changing the screen and turning off the speaker although the handpiece button was still being held down and energy was still being delivered to the handpiece. For reasons unknown, this particular lcd assembly is defective in that it is susceptible to the electromagnetic noise generated by the delivery of coag energy. It must be replaced. No issues were detected with the delivery of cut energy, which does not generator as much electromagnetic noise as the delivery of coag energy does. Root cause: the reported problem was replicated; the lcd assembly in this unit, for reasons unknown, is susceptible to the electromagnetic noise generated by the delivery of coag energy and does not always accurately, correctly reflect the status of the headpiece coag button. Note, however, that the presence or absence of coag energy to the handpiece always matched the status of the coag button.
Patient Sequence No: 1, Text Type: N, H10
[37877952]
A few minutes into the case, after the customer stopped depressing the coag button, the generator still showed as active and still gave the coag tone, however the hand piece wasnactive (there was no rf energy going to the hand piece). The generator was restarted and the issue was resolved. Approximately 10 minutes later, while being used on coag, the generator stopped showing as active, there was no activation tone and the screen did not indicated coag as active. This occurred although the customer was continuing to depress the coag button on the hand piece and the hand piece itself was still coagulating and still had rf energy going to it. The issue was resolved when the customer stopped depressing coag on the hand piece. Approximately 15 minutes later, after a subsequent activation on coag, when the customer stopped depressing the coag button, the generator still showed as active and still gave the coag tone, however the hand piece wasn't active and there was no rf energy going to the hand piece. A different generator was brought in and used with the same hand piece to successfully complete the case. Cut was not affected.
Patient Sequence No: 1, Text Type: D, B5
[103813950]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226420-2014-00119 |
| MDR Report Key | 4325925 |
| Report Source | 06,07,COMPANY REPRESENTATIVE, |
| Date Received | 2014-12-12 |
| Date of Report | 2015-04-03 |
| Date of Event | 2014-11-14 |
| Date Mfgr Received | 2015-04-03 |
| Date Added to Maude | 2014-12-29 |
| 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 | 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 II |
| Generic Name | GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER |
| Product Code | MUL |
| Date Received | 2014-12-12 |
| Returned To Mfg | 2014-11-26 |
| Model Number | PS100-102 |
| Catalog Number | PS100-102 |
| 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 | 2014-12-12 |