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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYGLASS DS DIGITAL CONTROLLER; LED LIGHT SOURCE
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BOSTON SCIENTIFIC CORPORATION SPYGLASS DS DIGITAL CONTROLLER; LED LIGHT SOURCE Back to Search Results
Model Number M0054665Z0
Device Problems Connection Problem (2900); Optical Problem (3001)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/01/2022
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that a spyscope ds ii and spy ds controller were used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.During the procedure, the image was lost, it seemed that the connection between the scope and controller was loose.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
The exact date of the event is unknown.The provided event date (b)(6) 2022 was chosen as a best estimate based on the date that the manufacturer became aware of the event.(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon 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.
 
Manufacturer Narrative
Block b3 (date of event): the exact date of the event is unknown.The provided event date 01mar2022 was chosen as a best estimate based on the date that the manufacturer became aware of the event.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 an adhesive stickers on cover, paint chips along the corners of cover, and along the front side of base.A functional evaluation noted a scorch and burn markings on the light engine light emitting diodes (led's).Heat damage to leds have caused led failure.Parts obsolete.Scrap requested and approved.Per the evaluation conducted by enercon technologies, the reported event was confirmed.A risk review confirms this is not a new or unanticipated event.The problem is unlikely related to manufacturing, as product analysis identified problems related to use and maintenance and did not identify any manufacturing defect.In addition, during a device history record review conducted by enercon, it was confirmed that the device met all manufacturing specifications.Although the number of procedures/recycles of the unit are unknown, improper handling of the device or wear/tear on internal components over time likely contributed to the event.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.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A search of the complaint database confirmed that no similar complaint exist for the specified lot.
 
Event Description
It was reported to boston scientific corporation that a spyscope ds ii and spy ds controller were used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.During the procedure, the image was lost, it seemed that the connection between the scope and controller was loose.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 DIGITAL CONTROLLER
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 Key14040259
MDR Text Key288776789
Report Number3005099803-2022-01897
Device Sequence Number1
Product Code NTN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142922
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM0054665Z0
Device Catalogue Number4665Z
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/04/2022
Is the Reporter a Health Professional? No
Date Manufacturer Received05/03/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/16/2015
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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