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

Model Number	EIWE
Medical Device Problem Codes	Crack (1135); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: WORKING ELEMENT
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 12200195
• Report Number: 1519132-2021-00014
• Device Sequence Number: 11682912
• Product Code: FBO
• UDI-Device Identifier: 00821925001916
• UDI-Public: 00821925001916
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K951972
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 06/28/2021
• Supplement Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 07/20/2021
• Supplement Report FDA Received Date: 08/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1