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

Model Number M0054661

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 10/06/2022

Event Type  malfunction  

Event Description

Spyscope ds ii with poor visualization.Extensive troubleshooting performed by staff with no changes.The boston scientific representative was contacted with no additional troubleshooting recommendation.A second scope was opened with the same issue being identified.Fda safety report id# (b)(4).

• Brand Name: SPYSCOPE DS II
• Type of Device: CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 15597521
• MDR Text Key: 301906773
• Report Number: MW5112612
• 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: Nurse
• Type of Report: Initial
• Report Date: 10/11/2022
• 2 Devices were Involved in the Event: 1 2

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: 04/26/2024
• Device Model Number: M0054661
• Device Catalogue Number: M0054661
• Device Lot Number: 29661008
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/12/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White