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

Model Number M00546650

Device Problems Poor Quality Image (1408); Adverse Event Without Identified Device or Use Problem (2993); Optical Problem (3001); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/15/2021

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

It was reported to boston scientific corporation that a spyglass ds digital controller were used during an cholangioscopy procedure performed in the pancreatic duct on (b)(6) 2021.During the procedure, the image of the spyscope catheter was interrupted.The light was blinking and the image was lost approximately 5 minutes into the procedure.The cables were adjusted and the problem was not resolved.The procedure was not completed due to this event and rescheduled.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 and front panel had damage.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A functional evaluation noted that the unit shut down immediately after boot up.The ducted cooling fan was not working which caused the shutdown.The light engine was disassembled.The catheter interface contacts and connector socket assembly were cleaned.The 32 conductor flex cable, 60mm cooling fan, front panel, keypad, top cover, cover gasket and rear bumper were replaced.Light engine calibration was performed and tests ran.Electrical safety tests were also performed.After replacements the unit passed all tests.Per the evaluation conducted by enercon technologies, the reported event of poor image quality and loss of visualization could not be duplicated.However, the unit shut down immediately after boot up.It is likely that the problem was intermittent.The ducted cooling fan was not working which cause the shutdown.A risk review confirms this is not a new or unanticipated event.As per report attached, 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.Based on gathered information, the most probable root cause is cause traced to component failure which indicates expected or random component failure without any design or manufacturing problem.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 spyglass ds digital controller were used during an cholangioscopy procedure performed in the pancreatic duct on (b)(6) 2021.During the procedure, the image of the spyscope catheter was interrupted.The light was blinking and the image was lost approximately 5 minutes into the procedure.The cables were adjusted and the problem was not resolved.The procedure was not completed due to this event and rescheduled.There were no patient complications reported as a result of this event.

• 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 Key: 12898300
• MDR Text Key: 286740285
• Report Number: 3005099803-2021-06272
• Device Sequence Number: 1
• Product Code: NTN
• UDI-Device Identifier: 08714729874348
• UDI-Public: 08714729874348
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K142922
• Number of Events Reported: 1
• 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: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00546650
• Device Catalogue Number: 4665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1