MAUDE Adverse Event Report: GYRUS ACMI, INC. GYRUS, PK-SP GENERATOR; ELECTROSURGICAL SYSTEM

Model Number 744000

Device Problems Output below Specifications (3004); Output Problem (3005)

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

Event Date 12/02/2022

Event Type  malfunction  

Event Description

User facility reported the device saline output is weak.The issue found during an unknown event.No harm was reported.No patient injury, no user injury reported due to the event.

Manufacturer Narrative

The subject device was not returned for evaluation.Communication with the customer (biomed) , technical assistance center (tac) support engineer was informed that the facility nurse stated that the saline output is weak and that another gyrus device was attached and worked fine.Customer stated not aware of any errors that occurred, however, when tac advised to retrieved the device error logs, it was determined that the only error that was present was error 400-26, indicated a user error related to accessories.The unit passed the self test and rebooted fine, customer informed tac that the case can be close.In addition, the customer stated it will relay, will inform facility nurse what error means and that it passed the self test, that the unit is in working order.Tac noted customer needed no further assistance.Supplemental report(s) will be submitted should any relevant new information is available.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation, as well as corrections to d5, e2, e3, and h8.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 7 years since the subject device was manufactured.The customer confirmed that the issue was resolved after the subject device was rebooted.Based on the results of the investigation, the root cause of the event (weak saline output) was unable to be identified, as the device was not returned for evaluation.Olympus will continue to monitor field performance for this device.

Event Description

Additional information was received which confirmed the reported event (saline output is weak) occurred during a procedure.

• Brand Name: GYRUS, PK-SP GENERATOR
• Type of Device: ELECTROSURGICAL SYSTEM
• Manufacturer (Section D): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer (Section G): 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: 16066435
• MDR Text Key: 308240502
• Report Number: 3003790304-2022-00368
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/28/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/02/2022
• Initial Date FDA Received: 12/29/2022
• Supplement Dates Manufacturer Received: 01/13/2023
• Supplement Dates FDA Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2016
• 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