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

Model Number M00546650

Device Problems Failure to Power Up (1476); Appropriate Term/Code Not Available (3191)

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

Event Date 05/28/2020

Event Type  malfunction  

Manufacturer Narrative

(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 mdr will be filed.

Event Description

It was reported to boston scientific corporation that a spyglass ds controller was used during a cholangioscopy procedure performed in the common bile duct on (b)(6) 2020.According to the complainant, during the procedure, there was no image due to failure of light source from the spyglass ds controller.Reportedly, all the cable connections were correctly placed, however, the blue light was off all time.The procedure was rescheduled due to this event.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

Event Description

It was reported to boston scientific corporation that a spyglass ds controller was used during a cholangioscopy procedure performed in the common bile duct on (b)(6) , 2020.According to the complainant, during the procedure, there was no image due to failure of light source from the spyglass ds controller.Reportedly, all the cable connections were correctly placed, however, the blue light was off all time.The procedure was rescheduled due to this event.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

Manufacturer Narrative

Block h6 (device codes): problem code a27 is being used to capture the reportable issue 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 and bottom cover had a cosmetic damaged, bumper was cracked, and 3 video inputs were damaged.A functional evaluation noted that the catheter interface board has no output.The light engine was disassembled.The catheter interface board and 32 conductor flex cable, the main housing and rear bumper, the 2 y/c video output connectors and 1 vga video output connector, the top cover and cover gasket were replaced.The connector socket assembly was cleaned.Light engine calibration was performed and a test was ran.All hardware items were re-torqued as necessary.An electrical safety test was performed and the unit passed all tests.The reported event was confirmed.Upon analysis, there was cosmetic damage presented, the bumper was cracked and 3 video inputs were damaged.Catheter interface board had no output.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 and wear/tear on internal components over time likely contributed to the event.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.Block h11: block d4 serial number and block e1 initial reporter email have been corrected.

• 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: 10184541
• MDR Text Key: 196128044
• Report Number: 3005099803-2020-02406
• 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: 09/13/2021

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: 07/12/2021
• Initial Date Manufacturer Received: 05/28/2020
• Initial Date FDA Received: 06/23/2020
• Supplement Dates Manufacturer Received: 08/20/2021
• Supplement Dates FDA Received: 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1