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

Model Number M00546610

Device Problem Fitting Problem (2183)

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

Event Date 05/04/2022

Event Type  malfunction  

Event Description

Spyglass¿ ds ii direct visualization system would not slide over guidewire, new device obtained, no patient harm, case proceeded 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: 14986134
• MDR Text Key: 295688482
• Report Number: 14986134
• 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: 06/22/2022

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: 28509632
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/22/2022
• Date Report to Manufacturer: 07/12/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/12/2022
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17155 DA