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

Model Number EIWE

Device Problem Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/21/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device has not yet been received for evaluation.The cause of the issue cannot be determined at this time.Multiple attempts have been made to obtain additional information and no further clarification is available.If additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that during a therapeutic surgical bladder resection the side of the resection scope omitted a flame.Staff did not see the flame however, smoke was smelled.The surgeons glove was burned.There was no known patient injury or harm reported.No user injury reported.It is not believed that there was any medical intervention required.It is unknown whether the surgeon's hand was burned.The procedure was able to be completed.

Manufacturer Narrative

This supplemental report is being submitted to provide review of the device history records (dhr),device evaluation and investigation conclusion.Please see updated sections: d4, d10,g4, g7, h2, h3,h4, h6 and h10.Device evaluation of the returned device, the reported issue was confirmed.It was found that the unit was leaking from block body and tube assay, causing the actuator block to spark.Burnt actuator block was observed.Dhrs for this product have been reviewed.All records indicate that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.The root cause of the reported failure cannot be determined at this time.Per instruction for use: the use of cords other than those specified may result in increased emissions or decreased immunity of the medical electrical equipment.Use only surgical gloves specifically designated by their manufacturer for electrosurgical procedure.In addition, examine the device prior to use.Do not use if damage is found.Olympus will continue to monitor complaints for this device.

• Brand Name: IGLESIAS WORKING ELEMENT
• Type of Device: IGLESIAS WORKING ELEMENT
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 11010869
• MDR Text Key: 221498409
• Report Number: 1519132-2020-00106
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/26/2021

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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/17/2020
• Initial Date FDA Received: 12/15/2020
• Supplement Dates Manufacturer Received: 01/25/2021
• Supplement Dates FDA Received: 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1