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

Model Number EIWE

Device Problem Sparking (2595)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/24/2018

Event Type  malfunction  

Manufacturer Narrative

The working element was not returned to olympus for evaluation.The cause of the reported event could not be determined at this time.However, based on similar reported events the most probable cause can be attributed to the debris or fluid inside the actuation block of the working element or the corresponding electrode is not connected properly inside the actuation block which can cause arcing.If the device is returned for evaluation at a later date, this report will be supplemented accordingly.The instruction manual warns users ¿introduce a new plasmakinetic supersect/loop device and the instrument cable into the sterile field.Insert the t-shaped connector on the instrument cable into the slot on the base of the white instrument mounting block.Ensure that the connector is fully seated within the block.¿ in addition, the oem has attributed this type of phenomenon to fluids invading the connection block causing an electrical short to occur due to the poor connection of the electrode, working element and cable.

Event Description

Olympus was informed that during set-up of an endometrial ablation procedure, a big spark occurred when the doctor was connecting the active cord to the working element.The spark was observed at the connection of the two devices.Both devices were replaced and the intended procedure was completed with similar devices without issue.It is unknown if the generator was on or if the cable was connected to the generator during the spark.The working element was inspected prior to set-up with no anomalies as the single use active cord was brand new.Both devices are expected to be returned for evaluation.1 of 2 devices.

Manufacturer Narrative

This supplemental report is being submitted to provide the device evaluation results.Only the working element was returned to olympus for evaluation.The lot number on the working element is rxkw and not lot# 2254942 that was originally reported.A visual inspection of the working element found char deposits inside the white actuation block.The working element was then tested with an olympus electrode (mle-24-015), active cord (dac) and esg-400 generator.There was no sparking/arcing observed during activation.A current leak test was performed on the working element and the it failed from the lock body and tube assembly area.Mechanism parts are working properly.Based on the investigation, the sparking could not be confirmed.However, based on similar reported events related to the reported device the most probable cause of the reported sparking could be attributed to an improper assembly of the electrode, working element and active cord or if moisture or debris is inside the actuation block where the electrode proximal end locks into, the sparking or arching could occur upon activation.The instruction manual provides instruction which states, ¿after assembling telescope and electrode to working element, insert active cord (1) into the actuation block (2) until it clicks into place.Connect the cord to the adapter.Check connection of cord with electrode to assure firm contact.The cord can be inserted into left or right side, up or down.Remove active cord prior to removing/ changing electrodes.¿.

• 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: 7667836
• MDR Text Key: 113643130
• Report Number: 2951238-2018-00396
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/06/2018

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 Catalogue Number: EIWE
• Device Lot Number: 2254942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/12/2018
• Initial Date FDA Received: 07/06/2018
• Supplement Dates Manufacturer Received: 08/16/2018
• Supplement Dates FDA Received: 09/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACTIVE CORD (DAC, LOT UNKNOWN)