MAUDE Adverse Event Report: GYRUS ACMI, INC IGLESIAS WORKING ELEMENT; K951972

Model Number EIWE

Device Problem Sparking (2595)

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

Event Date 01/16/2019

Event Type  malfunction  

Manufacturer Narrative

The reference device was not returned to olympus for evaluation.The exact cause of the reported event cannot be determined.However, 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 a transurethral resection of the prostate procedure, there was a spark and then smoke that occurred at the actuator block of the device when used with a non-olympus electrode (boston scientific).The monopolar resectoscope equipment was switched out to all gyrus pk sp bipolar resectoscope equipment and the intended procedure was completed.There was no patient harm reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the device evaluation results.A visual inspection of the received condition of the device found charring deposits inside electrode openings of the actuation block and cracks on o-ring inside the rack support.The device was then checked with olympus test electrode, active cord, and generator.There was no no spark or smoke observed during activation.In addition, the device passed the leak test.The cause of the reported event could not be conclusively determined as evaluation could not confirm the reported event and the concomitant devices that were used in the procedure were not returned along with the device for evaluation.Based on the similar reported complaint, the instruction manual provides instruction and warning that the device is to be used with a standard monopolar generator usa elite system, and recommended electrodes by oem.Also, if incomplete/improper assembly of the electrode to the active cord connector, are not locked in place, and resulted in an intermittent connection that could have produced arcing or sparking from the device.

Manufacturer Narrative

This supplemental report is being submitted to provide the dhr review for the referenced device.The device was manufactured in january 2018.A review of the dhr records were conducted and there were no defects, nonconforming issues or any corrective action issues during the manufacturing of the device.

• Brand Name: IGLESIAS WORKING ELEMENT
• Type of Device: K951972
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 8276708
• MDR Text Key: 134362197
• Report Number: 2951238-2019-00391
• 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,Followup
• Report Date: 03/20/2019

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: 01/25/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/16/2019
• Initial Date FDA Received: 01/24/2019
• Supplement Dates Manufacturer Received: 02/28/2019; 03/20/2019
• Supplement Dates FDA Received: 03/19/2019; 03/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1