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

Model Number 777000

Device Problem No Device Output (1435)

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

Event Date 06/08/2021

Event Type  malfunction  

Manufacturer Narrative

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

During the beginning of a ivor lewis esophagealectomy procedure, a halo handpiece failed to activate during the first attempted activation inside the patient using the g400 generator.A second hand piece was opened but also failed to activate.The facility observed an error code (not specified) initially upon start-up of the generator.The generator was restarted and the issue was resolved with no further error code observed.The procedure was completed using a ligasure device.No patient injury was reported.

Manufacturer Narrative

This supplemental report was submitted to provide the device evaluation, additional information from the olympus sales representative, corrections to sections b5 and d4, and to update sections: d8, d9, d10, g3, g6, h2, h3, h6 and h10.The subject device was returned to olympus (oaz) for evaluation.Upon inspection and testing, the evaluation confirmed multiple error 200 ref 79 logged and required a new (pkrf) board.The error 200 ref 79 is an internal failure where the (pkrf) thermistor temperature/resistance is out of range.The (pkrf) 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 olympus sales representative provided the correct sequence of events.During the beginning of a ivor lewis esophagealectomy procedure, the g400 generator unit started and produced an unspecified error code.The g400 was then restarted without error.A halo handpiece was connected and inserted in the patient then the halo handpiece failed to activate.A second halo handpiece was opened, connected and inserted in the same patient and failed to activate.The olympus devices were replaced and the intended procedure was completed using a ligasure device.No patient injury was reported.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the legal manufacturer and to update the following sections: g3, g6, h2, h4, h6 and h10.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.The local service group (oaz) performed an evaluation on the device.The unit had multiple error codes 200 ref 79 logged on the unit and determined the unit needs a new generator (pkrf) board.The unit was repaired and then passed all other inspections olympus will continue to monitor the field performance of this device.

• Brand Name: G400 GENERATOR, GYRUS
• Type of Device: G400 GENERATOR, GYRUS
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 12075511
• MDR Text Key: 258639648
• Report Number: 3003790304-2021-00119
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K050550
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2021
• 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: 06/24/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (2) OLYMPUS HACF0533; HALO HANDPIECE (2); HALO HANDPIECE (2)