MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYSCOPE DS II; CHOLEDOCHOSOPE AND ACCESSORIES, FLEXIBLE/ RIGID

Model Number GTIN08714729965404

Device Problem Defective Component (2292)

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

Event Date 11/08/2018

Event Type  malfunction  

Event Description

When a biopsy on a common bile duct was attempted via cholangioscopy with spybite biopsy forceps, the spyglass malfunctioned despite normal and careful maneuvers.

• Brand Name: SPYSCOPE DS II
• Type of Device: CHOLEDOCHOSOPE AND ACCESSORIES, FLEXIBLE/ RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; spencer IN 47460
• MDR Report Key: 8079276
• MDR Text Key: 128057649
• Report Number: MW5081395
• Device Sequence Number: 1
• Product Code: FBN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/14/2018

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 Expiration Date: 09/18/2019
• Device Model Number: GTIN08714729965404
• Device Catalogue Number: M00546610
• Device Lot Number: 22668577
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/15/2018
• 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