GENERATOR REFURB PULSAR PS100-100RF

MAUDE Adverse Event Report

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 REFURB PULSAR PS100-100RF manufactured by Medtronic Advanced Energy, Llc.

Event Text Entries

[15343972] Case #2 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


[15672098] (b)(4). Method: product received by manufacturer and pending inspection. Results: product received by manufacturer and pending inspection. Conclusion: product received by manufacturer and pending inspection. Product event: (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[33740443] 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


[33740444] 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


[103813463] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1226420-2014-00096
MDR Report Key4154732
Report Source06,07,COMPANY REPRESENTATIVE,
Date Received2014-10-09
Date of Report2014-12-03
Date of Event2014-09-10
Date Mfgr Received2014-12-03
Date Added to Maude2014-10-21
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKAYLEE BOISVERT
Manufacturer Street180 INTERNATIONAL DRIVE
Manufacturer CityPORTSMOUTH NH 03801
Manufacturer CountryUS
Manufacturer Postal03801
Manufacturer Phone6038426234
Manufacturer G1MEDTRONIC ADVANCED ENERGY, LLC
Manufacturer Street180 INTERNATIONAL DRIVE
Manufacturer CityPORTSMOUTH NH 03801
Manufacturer CountryUS
Manufacturer Postal Code03801
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGENERATOR REFURB PULSAR
Generic NameGENERATOR,ELECTROSURGICAL,COAGULATION,CANCER
Product CodeMUL
Date Received2014-10-09
Returned To Mfg2014-09-17
Model NumberPS100-100RF
Catalog NumberPS100-100RF
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC ADVANCED ENERGY, LLC
Manufacturer Address180 INTERNATIONAL DRIVE PORTSMOUTH NH 03801 US 03801


Patients

Patient NumberTreatmentOutcomeDate
10 2014-10-09

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