MAUDE Adverse Event Report: GYRUS ACMI INC FLEXIBLE URETEROPYELOSCOPE KIT

Model Number REPDUR-8

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/03/2014

Event Type  malfunction  

Event Description

The user facility reported that during a urology procedure, a rubber piece fell inside the pt.The physician was able to retrieve the rubber piece from the pt and procedure was successfully completed.No pt injury was reported.

Manufacturer Narrative

The device referenced in this report was returned to olympus for eval and confirmed that the device has a crack and a missing part of the biothane from the deflection cover on the flexible shaft side.The missing part of the biothane was not returned to olympus for investigation.In addition, the device was leaking due to a cut in the working channel.This was verified using a borescope.This phenomenon will occur when a broken or open forceps is inserted inside the biopsy channel, which would make a cut/tear.

• Brand Name: FLEXIBLE URETEROPYELOSCOPE KIT
• Type of Device: FLEXIBLE URETEROPYELOSCOPE KIT
• Manufacturer (Section D): GYRUS ACMI INC; 136 turnpike rd; southborough MA 01772 210
• Manufacturer (Section G): 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: 4019964
• MDR Text Key: 4694887
• Report Number: 2951238-2014-00291
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/03/2014

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: REPDUR-8
• Device Catalogue Number: REPDUR-8
• Device Lot Number: F01060A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/02/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/03/2014
• Initial Date FDA Received: 07/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2008
• 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