MAUDE Adverse Event Report: GYRUS ACMI, INC GYRUS, PK-SP GENERATOR

Model Number 744000

Device Problem No Device Output (1435)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The evaluation of the device found no output power malfunction at the rv1 due to faulty circuit boards.The generator was repaired to asset specifications and returned to asset stock.The asset was last serviced on (b)(6) 2021; no problems were found, inspection only.The investigation is ongoing; therefore, the root cause of the reported malfunction cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.

Event Description

The plasma kinetic superpulse generator was returned to the service center for an asset inspection.During testing, the generator was found to have a no output power malfunction due to faulty circuit boards.There was no reported allegation of a malfunction associated with the device and there was no patient involvement reported.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the legal manufacturer.The legal manufacturer performed the device history records for this device and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The investigation was completed by the legal manufacturer and determined that there is no manufacturing, material or processing related cause for this failure mode.Based on the physical evaluation, the cause of the reported event was attributed to a faulty boards (psu & pkrf) as the boards were replaced and the unit passed all functional tests afterwards.The legal manufacturer will continue to monitor the field performance of this device.

• Brand Name: GYRUS, PK-SP GENERATOR
• Type of Device: PK-SP GENERATOR
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 12006122
• MDR Text Key: 256556146
• Report Number: 3003790304-2021-00106
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00821925009271
• UDI-Public: 00821925009271
• Combination Product (y/n): N
• PMA/PMN Number: K031085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 744000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/20/2021
• Initial Date FDA Received: 06/15/2021
• Supplement Dates Manufacturer Received: 06/25/2021
• Supplement Dates FDA Received: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1