MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP./ GYRUS ACMI, INC. OLYMPUS FLEX CATCH NT, STONE RETRIEVAL DEVICE; DISLODGER, STONE, FLEXIBLE

Model Number NT4F19115

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 10/17/2019

Event Type  malfunction  

Event Description

Basket / tip of flex-catch stone basket broke off in pt.Broken basket / tip retrieved and removed from pt.Fda safety report id# (b)(4).

• Brand Name: OLYMPUS FLEX CATCH NT, STONE RETRIEVAL DEVICE
• Type of Device: DISLODGER, STONE, FLEXIBLE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP./ GYRUS ACMI, INC.
• MDR Report Key: 9220071
• MDR Text Key: 163575518
• Report Number: MW5090554
• Device Sequence Number: 1
• Product Code: FGO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• 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: 91807222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR