MAUDE Adverse Event Report: GYRUS ACMI, INC G400 GENERATOR, GYRUS; 00821925009004

Model Number 777000

Device Problem Output below Specifications (3004)

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

Event Date 02/02/2022

Event Type  malfunction  

Manufacturer Narrative

The referenced unit was returned for repair for evaluation.The fault log confirmed error 600 ref 1 was recorded ten times, however, the customer¿s reported issue could not be confirmed as no error 600 ref was not displayed during testing.Also, the service technician found the unit had low output attributed to a defective power supply unit and could not calibrate the boost and clamp into 1k due to a defective plasma blend board.Additionally, the hand switch test failed (left and right hand) with #9 error attributed to a defective auxiliary board.A software upgrade to the latest version is recommended and puncture/holes on the keypad.The investigation is ongoing; therefore, the root cause of the reported issue cannot be determined at this time.However, if additional information becomes available a follow up medical device report will be supplemented accordingly.

Event Description

Olympus was informed that the customer¿s g400 generator was returned to olympus for repair for a reported, ¿error 600 ref.One at each reboot ¿ internal issue w/auxiliary board¿ found during preparation for use.Upon inspection and testing, the service technician found the unit had low output attributed to a defective power supply unit and could not calibrate the boost and clamp into 1k attributed to a defective plasma blend board.No death, injury or harm was reported to olympus.

Manufacturer Narrative

This supplemental report is being submitted to correct the aware date of the initial mdr from february 10, 2022, to february 2, 2022, and to provide additional information based on the legal manufacturer¿s investigation.A dhr review has been performed; no issues (ncrs or deviations) with the manufacturing process have been indicated which might explain the failures observed.Because of this, it is likely that the manufacture of this device was not the cause of the failure reported.A complaint review was performed on 5apr2022 of all opened complaints for model number 777000.It was found that one other complaint had found issues with the plasma blend, aux and psu boards, like this complaint.One other complaint had reported plasma blend board issues and one complaint had reported aux board issues.No complaints were opened with the report of the error code 600 ref 1.A review of capas that have been opened for model number 777000 show that no capas that have been opened relate to the failures reported in this complaint.

• Brand Name: G400 GENERATOR, GYRUS
• Type of Device: 00821925009004
• Manufacturer (Section D): GYRUS ACMI, INC; 9600 louisiana ave n; brooklyn park MN 55445
• Manufacturer Contact: brian motter ; 800 west park drive; westborough, MA 01581 ; 4848965250
• MDR Report Key: 13717905
• MDR Text Key: 286921721
• Report Number: 3003790304-2022-00034
• 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: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• 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: 02/08/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2008
• 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