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

Model Number EIWE

Device Problems Smoking (1585); Arcing (2583)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/29/2017

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The cause for the reported event cannot be determined at this time.

Event Description

Olympus was informed that during a transurethral resection of the prostate (turp) procedure, the surgeon observing smoke and charring on the working element, while utilizing the resectoscope.It was reported that all the equipment was replaced and upon activation the surgeon observed arcing & smoke near the connection of the working element, active cord and electrode.The bleeding was as expected for this type of procedure.The intended procedure was completed.The procedure was prolonged by element 30 minutes.There was no patient injury.This report 1 of 3.

• Brand Name: IGLESIAS WORKING ELEMENT
• Type of Device: 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 ; 408935-512
• MDR Report Key: 6730890
• MDR Text Key: 80694919
• Report Number: 2951238-2017-00464
• Device Sequence Number: 1
• Product Code: FBO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK951972
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/20/2017

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: REXO
• Other Device ID Number: UDI
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/30/2017
• Initial Date FDA Received: 07/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: (2) MLE-24-012/S. UNK; EIWE WORKING ELEMENT /SN.UNK; RESCTOSCOPE/SN.UNK; DAC ACTIVE CORD SN. UNK