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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION SPYSCOPE DS II ACCESS & DELIVERY CATHETER; CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID Back to Search Results
Model Number M00546610
Device Problem Optical Problem (3001)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/29/2024
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that the two spyscope ds ii complaints and spy ds controller were used during cholangioscopy procedure for the treatment of common bile duct stones performed in the common bile duct on (b)(6) 2024.During the procedure, the spy ds controller had no image.Tried unplugging the scope as well as a new scope however still the controller had no image.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block h6 (impact codes): imdrf impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.
 
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Brand Name
SPYSCOPE DS II ACCESS & DELIVERY CATHETER
Type of Device
CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
780 brookside drive
spencer IN 47460
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key18939446
MDR Text Key338082827
Report Number3005099803-2024-01106
Device Sequence Number1
Product Code FBN
UDI-Device Identifier08714729965404
UDI-Public08714729965404
Combination Product (y/n)N
Reporter Country CodePO
PMA/PMN Number
K183636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 03/20/2024
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 NumberM00546610
Device Catalogue Number4661
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/29/2024
Initial Date FDA Received03/20/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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