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 Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.A visual inspection of the device found char marks inside the electrode insertion port of the white actuator block.The shaft of the device was critically bent and cracked at the proximal end damaging both the telescope and electrode channels which is indicative of user handling.In addition, there are scratches and a cold solder joint between the shaft and the nose cone.The exact cause of the reported event could not be conclusively determined as the concomitant devices were not returned along with the device for evaluation.However, based on the evaluation and similar reported events, the most probable cause of the reported event could be attributed to mis-assembly of electrode and activation cord or fluid/debris inside the actuator block that could have caused spark/arc discharge when the hf current was activated.The damage and the cold solder joint on device suggest that the device could have been repaired by a third party.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 therapeutic procedure, the device sparked at the electrode connection point.The device and boston scientific electrode were replaced with different devices and the intended procedure was completed.No patient injury was reported.

• Brand Name: IGLESIAS WORKING ELEMENT
• Type of Device: WORKING ELEMENT
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355124
• MDR Report Key: 7667956
• MDR Text Key: 113631367
• Report Number: 2951238-2018-00398
• Device Sequence Number: 1
• Product Code: FBO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K951972
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/06/2018

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: No Information
• Device Model Number: EIWE
• Device Catalogue Number: EIWE
• Device Lot Number: IC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/19/2018
• Initial Date FDA Received: 07/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1