MAUDE Adverse Event Report: GYRUS ACMI, INC ROLLER BAR (6/PK); ADULT RESECTOSCOPE

Model Number RB

Device Problem Sparking (2595)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/06/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the service center for evaluation.Therefore, the exact cause of the reported event cannot be determined.Upon return of the device, an evaluation will be performed, and a supplemental report will be submitted.

Event Description

The service center received a report of a rollerball (rb), and working element (eiwe)that sparked at the window area, white section, just before the connection to the ball.This report is for the roller ball/bar (model rb), lot number unknown that was used in the rollerball ablation.It was reported that the user facility has two lots at the time of the incident, and the device could have been from either lot number kr853397 or kr845885.The rollerball, working element, connection points to the generator and dac cable were all inspected prior to the procedure and no anomalies were observed.The physician was performing a therapeutic endometrial ablation when the spark was observed at the beginning of the procedure.The physician removed the device from the scope and observed that the connection point on the working element was charred and smelled like ¿burnt plastic¿.The observation of charred marks and that the roller ball/bar was burnt was reported.The cable was damaged at the distal end of the rb electrode and the eiwe working element.It was reported that there were no wires, no exposed metal and no abnormal observations were noted prior to the reported event.The generator setting was not reported and the cable was not bundled.The physician stopped the procedure and switched over to another type of device, novasure, to cauterize the inside of the patient¿s uterus and completed the intended procedure.It was reported there was no patient death or injury.This is report 1 of 2.

Manufacturer Narrative

The suspect rollerball was not returned to olympus and an evaluation cannot be performed.The concomitant medical product, iglesias working element (eiwe), used in conjuction with this rollerball, was returned and evaluated.The cause for the reported phenomenon could not be definitively determined; however, based upon evaluation of the associated eiwe, used in conjunction with this rollerball, it was determined that the likely cause of the reported event was moisture inside the active cord input area, resulting in the reported phenomenon.The evaluation of the associated eiwe has been documented and submitted on manufacturer report # 2951238-2020-00331.

Manufacturer Narrative

This supplemental report is being submitted to report the device evaluation results.The customer returned a rb roller bar electrode and reported "it began to spark at the window on the white part of the rollerball (area just before where the ball is connected).The connection spot on the working element when inspected was charred and smelled like burnt plastic.When the rollerball was removed from the scope, the end also appeared to be charred." visual inspection on the received condition noted multiple areas of charring on the electrode.The device could not be functionally tested due to the condition of the proximal and distal end sides.The insulation at the distal end leading up to the roller bar is damaged, possibly attributed to thermal damage.Additionally, there is foreign material found on the insulation at the distal end.The electrode is bent near the middle section, and there are scratches on the insulation portion.The proximal end-as previously stated-has charring.There are no sharp areas, or missing pieces.Although a definitive root cause is not known evaluations from similar reports concluded "likely there was moisture inside the active cord input area which probably caused the user¿s experience." in addition to moisture ingress, an electrical short may have been a result of improperly placed return electrode or loose connection.The device ifu (99-1082 rev be) notes, "prior to increasing any power settings, recheck all cables, connections, patient contacts, and irrigation fluid before proceeding.Once this is done, the power may be gradually increased.Note the tissue effect after each increase.This is a monopolar device.Make sure the patient return electrode (grounding plate) is properly positioned on the patient and connected to the electrosurgical generator.".

• Brand Name: ROLLER BAR (6/PK)
• Type of Device: ADULT RESECTOSCOPE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 9659597
• MDR Text Key: 204555309
• Report Number: 2951238-2020-00330
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• PMA/PMN Number: K890328
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/03/2020

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: RB
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/07/2020
• Initial Date FDA Received: 02/03/2020
• Supplement Dates Manufacturer Received: 05/05/2020; 07/24/2020
• Supplement Dates FDA Received: 05/06/2020; 08/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: WORKING ELEMENT,EIWEDAC CORD