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

Model Number EIWE

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus and evaluated.The reported problem could not be duplicated and a root cause could not be determined; however, it was determined the device failed the leakage test due to a leak from the lock body and tube assembly.Note: this mdr is being submitted retrospectively as part of a remediation effort related to recent system and process changes.A capa has been opened to manage the actions related to remediation of this issue and any required mdr reporting.

Event Description

A user facility reported to olympus that the electrode was stuck in working element and could not be removed.There was no patient injury or harm, associated with the problem, reported to olympus.The problem, as reported, was found during reprocessing.

Manufacturer Narrative

This supplemental report is submitted to correct the manufacturer facility number and provide the results of a device history record (dhr) review.Manufacturer facility number: (b)(4).The dhr for the product involved was reviewed.No anomalies were noted and it was verified the device was manufactured in accordance with documented specifications and procedures.

Manufacturer Narrative

Upon review, it was determined that this incident has previously been reported on report #1519132-2020-00021.This report has been determined to be a duplicate.

• Brand Name: IGLESIAS WORKING ELEMENT
• Type of Device: CYSTOURETHROSCOPE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 10389040
• MDR Text Key: 203380006
• Report Number: 3003790304-2020-00066
• Device Sequence Number: 1
• Product Code: FBO
• Combination Product (y/n): N
• PMA/PMN Number: K951972
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 04/08/2021

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: AC20070441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/26/2020
• Initial Date FDA Received: 08/10/2020
• Supplement Dates Manufacturer Received: 08/10/2020; 04/07/2021
• Supplement Dates FDA Received: 08/11/2020; 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1