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.
[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
| Report Number | 1226420-2014-00075 |
| MDR Report Key | 4043691 |
| Report Source | 06,07,COMPANY REPRESENTATIVE, |
| Date Received | 2014-08-28 |
| Date of Report | 2014-12-22 |
| Date of Event | 2014-07-31 |
| Date Mfgr Received | 2014-12-22 |
| Date Added to Maude | 2014-08-28 |
| 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 | 2014-08-28 |
| Returned To Mfg | 2014-10-22 |
| Model Number | PS100-100RF |
| Catalog Number | PS100-100RF |
| 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 |
| Manufacturer Address | 180 INTERNATIONAL DRIVE PORTSMOUTH NH 03801 US 03801 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-28 |