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

Model Number 744000

Device Problems No Device Output (1435); Output Problem (3005)

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

Event Date 06/24/2021

Event Type  malfunction  

Manufacturer Narrative

The returned device was received and evaluated at olympus (b)(4) repair site.Inspection found no output on the device due to faulty sprf and ss boards.The identified parts were replaced and device was repaired.Functional and electrical safety test was performed with no issues.Based on evaluations findings the failure found was attributed to faulty sprf and ss boards.Investigation is ongoing.This report will be supplemented accordingly following investigations.

Event Description

It was reported that the demo device was observed with no sp (superpulse) output.The issue found during device maintenance.There was no patient involvement reported due to the event.No user injury reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on customer response and updates.The following sections were updated: e1 ,g3, g6, h2, h6 and h10.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.A dhr (device history record) review has been performed; no issues (ncrs or deviations) with the manufacturing process have been indicated which might explain the failures observed.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: 12170345
• MDR Text Key: 261787005
• Report Number: 3003790304-2021-00124
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/06/2021

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?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/24/2021
• Initial Date FDA Received: 07/14/2021
• Supplement Dates Manufacturer Received: 07/14/2021; 08/05/2021
• Supplement Dates FDA Received: 07/23/2021; 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1