MAUDE Adverse Event Report: BOSTON SCIENTIFIC SPENCER DAKOTA NITINOL STONE RETRIEVAL DEVICE BASKET OPENSURE HANDLE; DISLODGER, STONE, BASKET, URETERAL, METAL

Catalog Number M00390501O

Device Problems Difficult to Open or Close (2921); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/11/2023

Event Type  malfunction  

Event Description

Provider asked for a dakota basket to retrieve the kidney stone.Staff checked the package integrity and expiration date, and opened the sterile supply.Upon checking the functionality of the basket, staff immediately noted that the basket would not close properly to be inserted into the instrument for stone retrieval.The dakota basket was removed from the sterile field, and a new dakota basket was opened and passed the function test.

• Brand Name: DAKOTA NITINOL STONE RETRIEVAL DEVICE BASKET OPENSURE HANDLE
• Type of Device: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC SPENCER; spencer IN 47460
• MDR Report Key: 16876814
• MDR Text Key: 314728861
• Report Number: MW5117252
• 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: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M00390501O
• Device Lot Number: 31272601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic