MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORP. SPYSCOPE DS II ACCESS AND DELIVERY CATHETER; CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number M00546610

Device Problem No Display/Image (1183)

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

Event Date 03/26/2021

Event Type  malfunction  

Event Description

During ercp, while in the bile duct, the spyscope ds ii video image was lost.Routine troubleshooting would not resolve the issue.A new "like" device was then opened and utilized to complete the procedure.Fda safety report id# (b)(4).

• Brand Name: SPYSCOPE DS II ACCESS AND DELIVERY CATHETER
• Type of Device: CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORP. ; marlborough MA 01752
• MDR Report Key: 11608122
• MDR Text Key: 243819481
• Report Number: MW5100520
• Device Sequence Number: 1
• Product Code: FBN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/31/2021

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 Expiration Date: 02/23/2023
• Device Model Number: M00546610
• Device Catalogue Number: M00546610
• Device Lot Number: 26859417
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/01/2021
• 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: 55 YR