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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYGLASS DS; LED LIGHT SOURCE

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BOSTON SCIENTIFIC CORPORATION SPYGLASS DS; LED LIGHT SOURCE Back to Search Results
Model Number M00546650
Device Problems Poor Quality Image (1408); Connection Problem (2900); Optical Problem (3001); Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/30/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
 
Event Description
Note: this report pertains to the spyscope ds ii access & delivery catheter and spyglass ds controller used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter and spyglass ds controller were used during a cholangioscopy procedure performed in the common biliary duct on (b)(6) 2021.During the procedure, image problems occur with artefacts, interference, lost image and the loading symbol appears after 30 minutes into the procedure.It was reported that when they moved the connector between the spyscope and the spyglass controller, they felt the image presents interference, and the image returns with some movements; like if the controller presented an electric connection problem.The physician decided to stop the procedure as he doesn't feel secure with the spyscope and the spyglass digital controller.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.
 
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Brand Name
SPYGLASS DS
Type of Device
LED LIGHT SOURCE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
ENERCON TECHNOLOGIES
25 northbrook dr
665
gray ME 04039
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key11734159
MDR Text Key247692750
Report Number3005099803-2021-01910
Device Sequence Number1
Product Code NTN
UDI-Device Identifier08714729874348
UDI-Public08714729874348
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K142922
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 04/27/2021
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 NumberM00546650
Device Catalogue Number4665
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/30/2021
Initial Date FDA Received04/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/19/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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