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

Model Number EIWE

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to the service center for evaluation.The working element failed leakage test due to leak from lock body and tube assembly.The instruction manual states section ¿cautions indicate that equipment may be damaged or may malfunction by misuse.¿.

Event Description

The service center was informed that during reprocessing the electrode was noted to be stuck in the working element.There was no patient injury reported.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The dhr review of the eiwe serial/lot number go was shipped as an rex scope, manufactured july 2010, did not find any defects, nonconforming issue or any corrective action issues during the assembly build of the device.All records indicate the device was manufactured in accordance with all applicable procedures and final product release criteria.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The investigation coding was added.

• Brand Name: IGLESIAS WORKING ELEMENT
• Type of Device: EIWE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 10171843
• MDR Text Key: 197090095
• Report Number: 1519132-2020-00021
• 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: company representative,user f
• 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: GO
• 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: 06/18/2020
• Supplement Dates Manufacturer Received: 08/11/2020; 04/06/2021
• Supplement Dates FDA Received: 08/20/2020; 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1