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

Model Number M00546650

Device Problems Poor Quality Image (1408); Appropriate Term/Code Not Available (3191)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/05/2020

Event Type  malfunction  

Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure 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 two spyscope ds ii and a spyglass ds controller used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii and a spyglass ds controller were used during a cholangioscopy procedure performed in the biliary duct on (b)(6) 2020.According to the complainant, during the procedure, when then physician introduced the spyscope ds ii into the patient and switched on the spyglass controller, the only image that showed on the screen was the boston scientific logo.Another spyscope ds ii was used; however, the same problem occurred.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that a spyscope ds ii and a spyglass ds controller were used during a cholangioscopy procedure performed in the biliary duct on (b)(6) 2020.According to the complainant, during the procedure, when then physician introduced the spyscope ds ii into the patient and switched on the spyglass controller, the only image that showed on the screen was the boston scientific logo.Another spyscope ds ii was used; however, the same problem occurred.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block a2: patient's exact age is unknown; however it was reported that the patient was over the age of 18.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 digital controller was analyzed by enercon technologies, and a visual evaluation noted that the top cover had finish damage.The front panel was cracked at the connector socket.A functional evaluation noted that the 32 conductor flex cable was disconnected due to a known problem.This disconnected cable caused unit to shut down before completing boot up.The front panel, keypad, 32 conductor flex cable, top cover, cover gasket and rear bumper were replaced.The light engine was disassembled.The catheter interface contacts and connector socket assembly were cleaned.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.Upon analysis, 2 common causes were identified: intermittent connection or disconnect of the 32-conductor flat flex cable and problems related to the user's cleaning procedure, such as dirty contacts/catheter socket and corrosion due to fluid ingress.An investigation is in place to address this problem.Most likely, problems traced to the design specifications (e.G.In the requirements, testing processes, hazard analysis, implementation strategy) could have affected the device performance and its integrity leading to the reported event.Therefore, cause traced to device design is the most probable cause selected for the complaint.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.

• 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 Key: 10904563
• MDR Text Key: 218725345
• Report Number: 3005099803-2020-05725
• Device Sequence Number: 1
• Product Code: NTN
• UDI-Device Identifier: 08714729874348
• UDI-Public: 08714729874348
• Combination Product (y/n): N
• PMA/PMN Number: K142922
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/10/2021

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 Number: M00546650
• Device Catalogue Number: 4665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Initial Date Manufacturer Received: 11/05/2020
• Initial Date FDA Received: 11/25/2020
• Supplement Dates Manufacturer Received: 02/16/2021
• Supplement Dates FDA Received: 03/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1