MAUDE Adverse Event Report: GYRUS ACMI, INC IGLESIAS WORKING ELEMENT

Model Number EIWE

Device Problems Crack (1135); Leak/Splash (1354)

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

Event Date 06/18/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device was received and evaluated.Inspection found the reported issue was confirmed.Upon inspection, the device handle was observed to be cracked and damaged.Further testing found the device failed leakage test due to leaked between handle.The red dot from the release button was missing.There were no problems with the passage and locking.Investigation is ongoing.This report will be supplemented accordingly following investigations.

Event Description

It was reported that during reprocessing, crack in the black handle of the device was observed.The issue occurred during reprocessing.There was no patient involvement on this event reported.No user injury reported.Device return testing found the device failed leakage test due to leaked between handle.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The device was an rex (repair exchange) unit manufactured in january 2008.Device history records were reviewed and showed the product met all specifications upon release.The provided dhrs do not include packaging or labeling operations.For this reason, the final manufacture date is not available.The reported failure mode has been addressed by the oem (original equipment manufacturer).To remediate handle fracture, a design change in the material of the handles has been implemented.The new handle material has been successfully validated for production release.This complaint device has an old design handle as it was manufactured before corrective actions were taken.Eiwe handle crack/break is a known failure mode and may be attributed to user mishandling or improper reprocessing.The device ifu (instruction for use) advises study the manual and other labeling thoroughly for safe handling and storage.Read all instructions carefully, including instructions for all generators and accessories.Misuse of instruments can cause injury to the patient and could have an adverse effect on the procedure being performed.Do not drop instruments or allow them to be struck by other objects.Olympus will continue to monitor complaints for this device.

• Brand Name: IGLESIAS WORKING ELEMENT
• Type of Device: WORKING ELEMENT
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 12200195
• MDR Text Key: 263407142
• Report Number: 1519132-2021-00014
• Device Sequence Number: 1
• Product Code: FBO
• UDI-Device Identifier: 00821925001916
• UDI-Public: 00821925001916
• Combination Product (y/n): N
• PMA/PMN Number: K951972
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/09/2021

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: EIWE
• Device Lot Number: RXAM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/28/2021
• Initial Date FDA Received: 07/20/2021
• Supplement Dates Manufacturer Received: 08/05/2021
• Supplement Dates FDA Received: 08/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1