MAUDE Adverse Event Report: GYRUS ACMI, INC. G400 GENERATOR, GYRUS; ELECTROSURGICAL

Model Number 777000

Device Problems Output above Specifications (1432); Output Problem (3005)

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

Event Type  malfunction  

Manufacturer Narrative

Device evaluation found the device output of the pbdes 50 w 1kr observed to be too high due to faulty plasma blend board.In addition, an error 200 ref 25 due to faulty (power supply unit) psu board was determined.Key pad found with many scratches and some punctures holes that needs to be replaced.Review of fault log found error 200 ref 26, five times indicated energy signal error, stuck low., error 200 ref 25 one time, indicated overdose signal error, permanently on/ check overdose calibration.And error 200 ref 25, two times, indicated rf_det signal error stuck low.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

During an asset return inspection with no complaint received form the customer, the device output of the pbdes 50 w 1kr found to be too high due to faulty plasma blend board.There was no patient involvement on this reported event.No user injury reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Section g2 was corrected to accurately label the report source as a healthcare professional.A review of the service history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the definitive root cause of the faulty plasma blend board could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: G400 GENERATOR, GYRUS
• Type of Device: ELECTROSURGICAL
• Manufacturer (Section D): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 15325367
• MDR Text Key: 304909623
• Report Number: 3003790304-2022-00188
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00821925009004
• UDI-Public: 00821925009004
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050550
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 777000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1