MAUDE Adverse Event Report: GYRUS ACMI INC. ULTRA-CATCH NT; STONE RETRIEVAL BASKET

Model Number NT4W18115

Device Problem Mechanical Jam (2983)

Patient Problem Perforation (2001)

Event Type  Injury  

Event Description

Olympus was informed that a pt sustained a perforation of the ureter during a stone removal procedure.The user experienced difficulty releasing the stone from the basket during the procedure.The stone was successfully released from the basket after multiple maneuvering of the device.The pt's current condition is unk at this time.Olympus followed up with the user facility via telephone and by mail to obtain more detailed info about the reported event but with no results.

Manufacturer Narrative

The device referenced in this report has not yet been returned to olympus for eval.The exact cause of the reported event could not be conclusively determined.If additional info is received at a later time this report will be supplemented.

• Brand Name: ULTRA-CATCH NT
• Type of Device: STONE RETRIEVAL BASKET
• Manufacturer (Section D): GYRUS ACMI INC.; 136 turnpike road; southborough MA 01772 210
• Manufacturer Contact: noemi schambach ; 2400 ringwood ave.; san jose, CA 95131 ; 4089355002
• MDR Report Key: 4539356
• MDR Text Key: 5539327
• Report Number: 2951238-2015-00101
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NT4W18115
• Device Catalogue Number: NT4W18115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2015
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other