GENERATOR PULSAR REFURBISHED 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 2014-08-28 for GENERATOR PULSAR REFURBISHED PS100-100RF manufactured by Medtronic Advanced Energy.

Event Text Entries

[18289299] A plasmablade device was being utilized to indirectly cauterize a small vessel, specifically, the vessel was grasped with metal forceps and the plasmablade device was activated on the metal forceps and upon activation the surgeon felt a shock in her hand that was holding the forceps. After the shock the surgeon noted a 1x1mm defect in her glove which exposed her skin and she also complained of a headache. The surgeon completed the case and subsequent to the case reported to the emergency room due to reports of chest pain, blurred vision, and a headache. An ekg was performed in the emergency room and results were negative. Upon a physical exam a scalp burn (where the surgeon had a bobby pin in her hair) was detected but did not require medical treatment. Surgeon complained of fatigue subsequent to the incident for 1-2 days but no additional medical treatment was sought. Both the device and generator are anticipated back for investigation, but are currently held up with the facilities risk management department.
Patient Sequence No: 1, Text Type: D, B5


[18461154] (b)(4). Method: product scheduled for return but not received by manufacturer for inspection. Eval code results: product scheduled for return but not received by manufacturer for inspection. Conclusion: product scheduled for return but not received by manufacturer for inspection. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[21240577] A plasmablade device was being utilized to indirectly cauterize a small vessel, specifically, the vessel was grasped with metal forceps and the plasmablade device was activated on the metal forceps and upon activation the surgeon felt a shock in her hand that was holding the forceps. After the shock the surgeon noted a 1x1mm defect in her glove which exposed her skin and she also complained of a headache. The surgeon completed the case and subsequent to the case reported to the emergency room due to reports of chest pain, blurred vision, and a headache. An ekg was performed in the emergency room and results were negative. Upon a physical exam a scalp burn (where the surgeon had a bobby pin in her hair) was detected but did not require medical treatment. Surgeon complained of fatigue subsequent to the incident for 1-2 days but no additional medical treatment was sought. Both the device and generator are anticipated back for investigation, but are currently held up with the facilities risk management department.
Patient Sequence No: 1, Text Type: D, B5


[21301296] Product event # (b)(4): lhr/dhr review: no associated manufacturing or servicing issues. Evaluation process: unit received in standard shipping container. Unit received in good condition with minor surface imperfections. No power cord, user manual, nor hand pieces were received with unit. Internal visual inspection found nothing moving or broken in unit. Unit delivered rf energy correctly into fixed resistors. The error log revealed that the unit was powered up on at least 1 unique day while in the field (error log indicates that the ucb clock battery died before it was first powered up in the field. ) error log contains 1 e1 (both handpiece buttons pushed simultaneously,) 1 e3s (patient return electrode has poor connection,) 2 e9s (monopolar output activated without patient return electrode connected,) 12 e11s (patient return electrode disconnected,) and 1 f2 (self-test fault. ) all error log entries are considered? Normal use? Errors and are not indicative of a problem with the unit. Step 5. 32 of tp-0004 was performed to verify that the unit would successfully go into the lower-power rf leakage mode when the rf leakage path was detected. Unit successfully and consistently went into rf leakage mode in all required configurations. Root cause: the service department is unable to confirm whether the surgeon received an electric shock. The unit successfully passed all testing involving delivery of energy, which demonstrates that it is performing as designed. Ucb real-time clock battery died due to age. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[86569452] Corrected information: no eval explain code.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1226420-2014-00075
MDR Report Key4043691
Report Source06,07,COMPANY REPRESENTATIVE,
Date Received2014-08-28
Date of Report2014-12-22
Date of Event2014-07-31
Date Mfgr Received2014-12-22
Date Added to Maude2014-08-28
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 PULSAR REFURBISHED
Generic NameGENERATOR,ELECTROSURGICAL,COAGULATION,CANCER
Product CodeMUL
Date Received2014-08-28
Returned To Mfg2014-10-22
Model NumberPS100-100RF
Catalog NumberPS100-100RF
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC ADVANCED ENERGY
Manufacturer Address180 INTERNATIONAL DRIVE PORTSMOUTH NH 03801 US 03801


Patients

Patient NumberTreatmentOutcomeDate
10 2014-08-28

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.