MAUDE Adverse Event Report: GYRUS ACMI, INC. ELECTRODE

Model Number 257F6

Device Problem Component Missing (2306)

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

Event Date 01/13/2023

Event Type  malfunction  

Manufacturer Narrative

Device identification: (b)(4).The device was returned to olympus for evaluation and the customer's allegation was confirmed.The device evaluation found the electrode cap was not on the black connector.The black connector was missing exposing the internal wires which measured 5mm from the proximal end.The proximal wires were charred/burned and the green insulation appeared to be slightly melted on the side and contained minor scratches.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device was manufactured in december 2021.Based on the results of the investigation, the observed damage possibly happened when the device was being used.The observed damage was likely due to user mishandling.However, a definitive root cause could not be determined.The following information is stated in the instructions for use (ifu): "prior to use, examine the electrode insulation for splits, cracks, holes, or other imperfections.Do not use a damaged product;" "refer to the appropriate operating and maintenance manual for the endoscope with which the flexible electrode is to be used for additional cautions and instructions." olympus will continue to monitor the field performance of this device.

Event Description

The customer reported to olympus, the electrode cap was not on the when the device was opened.The issue was an out of box failure.There were no reports of patient harm.

• Brand Name: ELECTRODE
• Type of Device: ELECTRODE
• Manufacturer (Section D): GYRUS ACMI, INC.; 93 north pleasant st.; norwalk OH 44857
• Manufacturer (Section G): GYRUS ACMI, INC.; 93 north pleasant st.; norwalk OH 44857
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16728333
• MDR Text Key: 313664135
• Report Number: 1519132-2023-00014
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/12/2023

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: 257F6
• Device Lot Number: AF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/13/2023
• Initial Date FDA Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1