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

Model Number M00546610

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 06/15/2022

Event Type  malfunction  

Event Description

Spyscope¿ ds ii flexible video choledochoscope not performing correctly, staff attempted to troubleshoot connections, contacted boston scientific representative who assisted troubleshooting over the phone.Case continued without further 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: 15137994
• MDR Text Key: 296968168
• Report Number: 15137994
• 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
• Report Date: 07/15/2022

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 Model Number: M00546610
• Device Catalogue Number: M00546610
• Device Lot Number: 29295239
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/15/2022
• Date Report to Manufacturer: 08/01/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 16790 DA