MAUDE Adverse Event Report: GYRUS ACMI, INC FLEX-CATCH 4 WIRE NITINOL BASKET; EXTRACTOR, STONE REMOVAL

Model Number NT4F19115

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/05/2020

Event Type  malfunction  

Manufacturer Narrative

Device was received and evaluated at hinode olympus japan.Evaluation determined that one of the wires was disconnected from the welded part at the tip of the basket.The probable cause of the reported failure likely that the welded part of the wire at the tip of the basket was damaged when pulling the slider while holding the stone and trying to close the basket.Photo of the subject device was provided for original equipment manufacturer further evaluation and investigation.If additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported during an unspecified procedure, when attempting to capture a stone in the basket, the wire broke.Another similar device was used and the intended procedure was completed.No patient harm or injury was reported due to the event.No user injury reported.

Manufacturer Narrative

This supplemental report is being submitted to provide review of the device history records (dhr), unique device identifier (udi) number and investigation conclusion.Photos of the subject device was evaluated.Evaluation determined that one of the wires was disconnected from the welded part at the tip of the basket.Evaluation was performed and confirmed that one wire was disconnected from the welded part at the tip of the basket.Review of the dhr showed that the production has been done according to the valid specifications.All process steps and all inspection records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.Olympus will continue to monitor complaints for this device.

• Brand Name: FLEX-CATCH 4 WIRE NITINOL BASKET
• Type of Device: EXTRACTOR, STONE REMOVAL
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 10778611
• MDR Text Key: 214347801
• Report Number: 3003790304-2020-00123
• Device Sequence Number: 1
• Product Code: FGO
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT-FGO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NT4F19115
• Device Lot Number: 91904966
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1