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

Lot Number 28104072

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 01/12/2022

Event Type  malfunction  

Event Description

Camera of spyscope ds ii access & delivery catheter not working properly during medical procedure.The camera component was replaced with a new camera.There was a nominal delay in switch and procedure continued without incident.

Event Description

Camera of spyscope ds ii access & delivery catheter not working properly during medical procedure.The camera component was replaced with a new camera.There was a nominal delay in switch and procedure continued without incident.

• Brand Name: SPYSCOPE¿ DS II
• Type of Device: CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 13522847
• MDR Text Key: 285542748
• Report Number: 13522847
• Device Sequence Number: 1
• Product Code: FBN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/01/2022

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 Lot Number: 28104072
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/01/2022
• Date Report to Manufacturer: 02/14/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/14/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/14/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24455 DA