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 2014-10-16 for GENERATOR PS100-100 PULSAR manufactured by Medtronic Advanced Energy, Llc.
[5020901]
During a care the surgeon reported that there was reversed activation on the pulsar i generator, specifically when the cut button is pressed, the generator shows coag mode is activated and when the coag is pressed, the generator shows cut mode is activated. No patient impact, patient information unavailable.
Patient Sequence No: 1, Text Type: D, B5
[12256791]
(b)(4). Method/results/conclusion: product returned and analysis results pending.
Patient Sequence No: 1, Text Type: N, H10
[33001261]
Product analysis # (b)(4). Evaluation process: unit received in standard shipping container. Unit received in poor condition with case staining, rear nylon screw in base of unit is broken, and minor surface imperfections. No power cord, user manual, nor handpieces were received with unit. Internal visual inspection found nothing moving or broken in unit. The error log revealed that the unit was powered up on at least 145 unique days while in the field (log indicates that the ucb clock battery died on or after 08mar2014. ) error log contains 56 e1s (both handpiece buttons pushed simultaneously,) 36 e2s (both foot pedal buttons pushed simultaneously,) 13 e3s (patient return electrode has poor connection,) 9 e5s (monopolar handpiece has reached end of life,) 12 e9s (monopolar output activated without patient return electrode connected,) 144 e11s (patient return electrode disconnected,) 1 f2 (self-test fault,) 3 f5s (rf module monitor has detected rf module failure at boot,) 2 f6s (rf module communication with the controller processor has failed,) and 1 f8 (power supply voltage is too low. ) all error log entries, except f5, f6 <(><<)>(><(>&<)><(><<)>)> f8 faults, are considered? Normal use? Errors and are not indicative of a problem with the unit. An f5 fault will o ccur when the dc power supply boots into an uncertain state. By design, the system must be power-cycled before it can deliver rf energy. An f6 fault will occur when he communication between tow internal pcbs (the universal controller board and the rf controller bo ard) becomes garbled. By design, energy is shut off and the system must be power-cycled before it can again deliver rf energy. The low frequency of occurrence of these faults suggests that they are not major issues with this unit. The unit will be monitored for future occurrences of these faults. F8 faults can occur if the voltage at the? Vdda? Input of the dsp (3. 30vdc) is significantly larger than the voltage at the? Vdd? Input of the dsp. The voltage for the? Vdd? Input is generated relatively far away, at the low voltage power supply (lvps), and experiences a voltage drop by the time it reaches the dsp. A difference between vdd and vdda can cause an oscillation to the? Vdda? Voltage, which leads to incorrect analog voltage readings and, hence, false f8 faults. Adjusting the lvps to increase vdd (from 3. 19v upon arrival to 3. 29v after adjustment of vps from 3. 21v to 3. 31v) should eliminate future spurious f8 faults. Root cause: the reported condition could not be replicated by the service department: the keying of cut/coag by either handpiece or foot pedal activation correctly yielded the desired activation of cut or coag energy. Case staining is caused by the use of aggressive cleaning agents in the field. The broken screw in the result of rough handling in the field. Real-time clock battery died due to age. The single f8 fault (from 28fab2014) was likely due to the difference in digital and analog 3. 3 voltages at the dsp on the dc power supply pcba. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[33001262]
During a care the surgeon reported that there was reversed activation on the pulsar i generator, specifically when the cut button is pressed, the generator shows coag mode is activated and when the coag is pressed, the generator shows cut mode is activated. No patient impact, patient information unavailable.
Patient Sequence No: 1, Text Type: D, B5
[103815272]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226420-2014-00102 |
| MDR Report Key | 4176350 |
| Report Source | 06,07,COMPANY REPRESENTATIVE, |
| Date Received | 2014-10-16 |
| Date of Report | 2015-01-15 |
| Date of Event | 2014-09-16 |
| Date Mfgr Received | 2015-01-15 |
| Date Added to Maude | 2014-10-30 |
| 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 PS100-100 PULSAR |
| Generic Name | GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER |
| Product Code | MUL |
| Date Received | 2014-10-16 |
| Returned To Mfg | 2014-10-03 |
| Model Number | PS100-100 |
| Catalog Number | PS100-100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2014-10-16 |