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

Model Number 744000

Device Problems Energy Output Problem (1431); No Device Output (1435)

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

Event Type  malfunction  

Event Description

It was reported the device does not work and provided no further details, customer is checking the output and is not getting no output.The issue found during an unknown event.No harm was reported.No patient harm, no user injury reported due to the event.

Manufacturer Narrative

Technical assistance center (tac) support engineer communication with the customer (biomed) instructed on how to review the error log.The error log was found with no listed errors in the log.Tac provided troubleshooting with the customer and in addition, provided the pk superpulse biomed service manual.Tac instructed customer to perform an out put check with the following cables: test cable 560084-001 and connector cable 39000.In a follow up communication, the customer reported that they were able to perform a successful functional check on the unit and have returned it to service.Tac noted the "output check passed, device was put back into use".The subject device was not returned to olympus, it is unknown at this time what have caused the reported issue.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.A review of the service history record found no deviations that could have caused or contributed to the reported phenomenon.The issues reported in this complaint are likely not from the repair of this device.Based on the results of the investigation, it was noted that the customer was not testing the unit's output properly.Olympus will continue to monitor field performance for this device.

• Brand Name: GYRUS, PK-SP GENERATOR
• Type of Device: ELECTROSURGICAL GENERATOR
• 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: 15961411
• MDR Text Key: 307820866
• Report Number: 3003790304-2022-00330
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00821925009271
• UDI-Public: 00821925009271
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/08/2023

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: 11/14/2022
• Initial Date FDA Received: 12/12/2022
• Supplement Dates Manufacturer Received: 02/13/2023
• Supplement Dates FDA Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2007
• 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