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

Model Number 744000

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

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

Event Date 04/15/2021

Event Type  malfunction  

Manufacturer Narrative

During a call with tac (technical assistance center) support engineer it was determined that the customer is testing the output of the device and wanted to know if there is a tolerance/range to the reading on the fluke test equipment for output reading.Tac advised the customer to locate the biomedical manual and once located, customer was advised to reference the biomedical manual as there is a output range limit for each of the output test.To date there are no other issues reported.It is likely that the reported issue was resolved as customer did not call back for additional information.Based on tac conversation with the customer the probable cause of the issue could be due to use handling and or training issue.This report will be supplemented accordingly following investigations.

Event Description

The user facility reported that the device is not getting hot enough.The issue occurred during an unknown event.There was no patient involvement, no user injury reported due to the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The following sections were updated: g3, g6, h2, h4, h6, and h10.A device history record review was not performed as this device has been serviced before.A review of the service history record review shows no abnormalities.The customer reported that their pk-sp generator is not getting hot enough.This was noted to be from the customer when testing the generator.Not much more information was provided by the customer and multiple attempts to gather more information was unsuccessful.The device was not returned to olympus for further evaluation.Olympus will continue to monitor the field performance of this device.

• Brand Name: GYRUS, PK-SP GENERATOR
• Type of Device: GYRUS, PK-SP GENERATOR
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 11860249
• MDR Text Key: 252383252
• Report Number: 3003790304-2021-00093
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00821925009271
• UDI-Public: 00821925009271
• Combination Product (y/n): N
• PMA/PMN Number: K031085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 06/16/2021

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/29/2021
• Initial Date FDA Received: 05/20/2021
• Supplement Dates Manufacturer Received: 06/14/2021
• Supplement Dates FDA Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1