MAUDE Adverse Event Report: GYRUS ACMI, INC ULTRA-CATCH NT (1.8 FR X 115 CM) STONE RETRIEVAL DEVICE

Model Number NT4W18115

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/15/2017

Event Type  malfunction  

Manufacturer Narrative

The referenced device will not be returned to olympus for evaluation as it was discarded after the procedure.The exact cause of the reported event cannot be determined; however, the mostly likely cause of the reported event can be attributed to a higher than normal force applied on the joint by the operator when extracting a large stone.The instruction manual warns users: certain objects may be too large to remove endoscopically with this retrieval system.To avoid complications fluoroscopic x-ray or some means of identification of an objects size should be used prior to attempting to remove.Do not use this device if the object is too large to be removed and/or cannot be securely held in the stone dislodger.Inspect the device for any visible damage such as kinks or broken stone dislodger wires.Test the device by opening, closing and rotating it several times before being introduced into the patient.

Event Description

The user facility informed olympus that while performing a stone retrieval the basket separated from the wire and fell into the patient.It was reported that the basket was retrieved.It is unknown if the intended procedure was completed.There was no patient injury reported.

• Brand Name: ULTRA-CATCH NT (1.8 FR X 115 CM) STONE RETRIEVAL DEVICE
• Type of Device: STONE RETRIEVAL DEVICE
• 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: 7180771
• MDR Text Key: 97796854
• Report Number: 2951238-2018-00011
• Device Sequence Number: 1
• Product Code: FGO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• 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: 01/10/2018

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: NT4W18115
• Device Catalogue Number: NT4W18115
• Device Lot Number: UNKNOWN
• Other Device ID Number: UDI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/17/2017
• Initial Date FDA Received: 01/10/2018
• 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