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

Model Number EIWE-PKFL

Device Problem Crack (1135)

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

Event Date 07/23/2019

Event Type  malfunction  

Manufacturer Narrative

The working element will not be returned to the service center for evaluation as it was discarded during the procedure.The exact cause of the reported event could not be conclusively determined at this time.The instruction manual warns users ¿to ensure satisfactory performance, perform the prescribed inspections as recommended.Examine this device prior to use.Do not use if damage is found.¿.

Event Description

The service center was informed that during a therapeutic transurethral resection of bladder tumor (turbt) procedure, the working element was cracked causing the electrode to short out.There was no report of sparking or smoke.The generator settings were 160/80.The cracked working element was discarded and a replacement was used with the same electrode and generator to complete the procedure.The procedure was prolonged by just a few minutes.There was no unexpected bleeding.There was no patient injury reported.

• Brand Name: PK FRONT LOAD,IGLESIAS,WORKING ELEMENT
• Type of Device: PK FRONT LOAD,IGLESIAS,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: 8910940
• MDR Text Key: 154898712
• Report Number: 2951238-2019-01059
• Device Sequence Number: 1
• Product Code: FBO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021166
• 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: 08/20/2019

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-PKFL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/23/2019
• Initial Date FDA Received: 08/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ELECTRODE WA22367A; GYRUS, PK-SP GENERATOR