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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 Connection Problem (2900); Appropriate Term/Code Not Available (3191)
Patient Problem Insufficient Information (4580)
Event Date 05/10/2021
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 procedure performed on (b)(6) 2021.During the preliminary check, the physician powered on the controller, checked the correct power switch and connected the spyscope ds ii into the controller, but it did not work.They used two demo scope with this controller; however, an image was still not visible.The procedure was not completed due to this event.It was reported that the procedure was performed the next day, after the spyglass ds was exchanged.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
 
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 procedure performed on (b)(6) 2021.During the preliminary check, the physician powered on the controller, checked the correct power switch and connected the spyscope ds ii into the controller, but it did not work.They used two demo scope with this controller; however, an image was still not visible.The procedure was not completed due to this event.It was reported that the procedure was performed the next day, after the spyglass ds was exchanged.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
 
Manufacturer Narrative
Block h6 (device codes): medical device problem code a27 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 there were no defects, wear and tear, or damaged.A functional evaluation noted that there were no functional problems found.The light engine was disassembled.The catheter interface contacts and connector socket assembly were cleaned.Re-torqued all hardware items where necessary.Light engine calibration was performed and a test was ran.An electrical safety test was performed and the unit passed all tests.The reported event was not confirmed.Upon analysis, there were no functional problems found.A risk review confirms this is not a new or unanticipated event.During a device history record review conducted by enercon it was confirmed that the device met all manufacturing specifications.Based on all gathered information, the most probable root cause of this event is no problem detected.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.
 
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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
MDR Report Key11946359
MDR Text Key254537966
Report Number3005099803-2021-02616
Device Sequence Number1
Product Code NTN
UDI-Device Identifier08714729874348
UDI-Public08714729874348
Combination Product (y/n)N
PMA/PMN Number
K142922
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 08/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2021
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
Date Returned to Manufacturer06/16/2021
Date Manufacturer Received08/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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