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 Known Impact Or Consequence To Patient (2692)

Event Date 04/22/2020

Event Type  malfunction  

Event Description

Patients were scheduled for an ercp with spyscope to allow direct visualization of pd stones and spyscope failed during use.Event 1: spyscope failed during use, event 2: spyscope x 2 failed during use.

• 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: 10091531
• MDR Text Key: 192194182
• Report Number: 10091531
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 08714729965404
• UDI-Public: (01)08714729965404(17)220304(10)25301532
• 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: 04/29/2020

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 Model Number: M00546610
• Device Lot Number: 25301532
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/29/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/27/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1