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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 Failure to Power Up (1476); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/31/2022
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that a spy ds controller was used during an endoscopic retrograde cholangiopancreatography (ercp) with spyglass investigation procedure performed in the common bile duct on (b)(6) 2022.During the procedure, the spyglass does not boot properly.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.
 
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
It was reported to boston scientific corporation that a spy ds controller was used during an endoscopic retrograde cholangiopancreatography (ercp) with spyglass investigation procedure performed in the common bile duct on (b)(6) 2022.During the procedure, the spyglass does not boot properly.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): impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.Block h10: the returned spyglass ds digital controller was analyzed by enercon technologies, and a visual evaluation noted that the top cover had a finish damage and had sticky residue inside connector socket.A functional evaluation noted that video was intermittent.This was caused by fibers and unknown particles on the catheter interface contacts.Contacts were cleaned to restore video.Per the evaluation conducted by enercon technologies, the reported event could not be duplicated.A risk review confirms this is not a new or unanticipated event.As per report attached, the issue is unlikely related to manufacturing, as product analysis identified issues related to use and maintenance and did not identify any manufacturing defect.Based on all gathered information, the conclusion code selected for this event is cause traced to maintenance, which indicates that problems are traced to improper routine or preventative maintenance.
 
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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 Key14792923
MDR Text Key303235821
Report Number3005099803-2022-03364
Device Sequence Number1
Product Code NTN
UDI-Device Identifier08714729874348
UDI-Public08714729874348
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
K142922
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,Followup
Report Date 09/20/2022
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 Operator Health Professional
Device Model NumberM00546650
Device Catalogue Number4665
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/31/2022
Initial Date FDA Received06/23/2022
Supplement Dates Manufacturer Received08/29/2022
Supplement Dates FDA Received09/20/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/08/2015
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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