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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 M0054665Z0
Device Problems Optical Problem (3001); Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/17/2021
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 mdr will be filed.
 
Event Description
Note: this report pertains to the two spyscope ds ii, spysnare and spyglass ds controller used during the same procedure.It was reported to boston scientific corporation that the two spyscope ds ii, spysnare and spyglass ds controller were used during a cholangioscopy procedure performed in the common bile duct (cbd) on (b)(6) 2021.During the procedure, the image of the first spyscope ds ii was lost less than 5 minutes into the procedure.A second spyscope ds ii was used, however, the image was also lost.An autolith electrohydraulic lithotripsy (ehl) probe was used when the visualization problems occurred.The spyscope ds ii was disconnected and reconnected back to the controller, and the controller was rebooted several times; however, the problem was not resolved.They also tried to used a spysnare, and it failed to open when it was inside the scope and inside the patient.The procedure was rescheduled due to this event.There were no patient complications reported as a result of this event.
 
Event Description
Note: this report pertains to the two spyscope ds ii, spysnare and spyglass ds controller used during the same procedure.It was reported to boston scientific corporation that the two spyscope ds ii, spysnare and spyglass ds controller were used during a cholangioscopy procedure performed in the common bile duct (cbd) on (b)(6) 2021.During the procedure, the image of the first spyscope ds ii was lost less than 5 minutes into the procedure.A second spyscope ds ii was used, however, the image was also lost.An autolith electrohydraulic lithotripsy (ehl) probe was used when the visualization problems occurred.The spyscope ds ii was disconnected and reconnected back to the controller, and the controller was rebooted several times; however, the problem was not resolved.They also tried to used a spysnare, and it failed to open when it was inside the scope and inside the patient.The procedure was rescheduled due to this event.There were no patient complications reported as a result of this event.
 
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 the top cover and front panel had stickers all over.A functional evaluation noted that the catheter interface contacts required cleaning.The y/c video outputs were worn.The light engine was disassembled.The catheter interface contacts and connector socket assembly were cleaned.The y/c video output connectors, front panel, keypad, flex cable, rear bumper, top cover and cover gasket were replaced.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 confirmed.The damaged components were replaced and cleaned, and the unit passed all tests.Based on all gathered information, the most probable root cause of this event complaint is cause traced to 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.
 
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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 Key11633986
MDR Text Key244416039
Report Number3005099803-2021-01577
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,health
Type of Report Initial,Followup
Report Date 08/09/2021
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 NumberM0054665Z0
Device Catalogue Number4665Z
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/06/2021
Initial Date Manufacturer Received 03/19/2021
Initial Date FDA Received04/08/2021
Supplement Dates Manufacturer Received07/15/2021
Supplement Dates FDA Received08/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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