MAUDE Adverse Event Report: GYRUS ACMI INC CLASSIC SERIES REUSABLE ACTIVE CORD

Model Number C650-129A

Device Problems Fire (1245); Arcing (2583); Electrical Shorting (2926)

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

Event Date 04/02/2015

Event Type  malfunction  

Event Description

Olympus was informed that during a therapeutic cysto-bladder fulguration the active cord peeled apart during use and began shorting out before igniting into an open flame.The user facility reported that this caused no impact on the outcome of the procedure.The intended procedure was completed with a different similar device.There was no patient injury reported.Olympus followed up with the user facility regarding the reported event to obtain additional information but with no results.

Manufacturer Narrative

The device referenced in this report has not been returned for evaluation.As a result, the reported event could not be conclusively determined at this time.If further information becomes available or if the device is returned for investigation, this report will be supplemented accordingly.

• Brand Name: CLASSIC SERIES REUSABLE ACTIVE CORD
• Type of Device: CLASSIC SERIES REUSABLE ACTIVE CORD
• Manufacturer (Section D): GYRUS ACMI INC; 136 turnpike rd; southborough MA 01772 210
• Manufacturer Contact: noemi schambach ; 2400 ringwood ave.; san jose, CA 95131 ; 4089355002
• MDR Report Key: 4718007
• MDR Text Key: 5739216
• Report Number: 2951238-2015-00180
• 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: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/20/2015

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: C650-129A
• Device Catalogue Number: C650-129A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2015
• Initial Date FDA Received: 04/20/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1