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

Model Number M0054665Z0

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 11/24/2020

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 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 an endoscopic retrograde cholangiopancreatography (ercp) procedure performed in the common bile duct (cbd) on (b)(6) 2020.According to the complainant, during the procedure, the controller was not working.It powers up but will go back to the main screen, and there is no image.Reportedly, a second spyscope ds ii was used; however, this did not resolve the image problem.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.

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 digital controller was analyzed by enercon technologies, and a visual evaluation noted that the front panel was cracked and the top cover had finish damaged.A functional evaluation noted a build up of unknown material present on the contacts preventing a good connection with the scope contact pads.The light engine was disassembled.The catheter interface contacts and connector socket assembly were cleaned.The front panel, keypad, 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.Upon analysis, the front panel was cracked and the top cover had finish damaged.It was also found that an unknown material was present on the contacts preventing a good connection with the scope contact pads.Although the number of procedures/recycles of the unit are unknown, handling during use and reprocessing over time likely contributed to the event.Based on all gathered information, the most probable root cause of this complaint is cause traced to maintenance which indicates that problems are traced to improper routine or preventative 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.

Event Description

It was reported to boston scientific corporation that a spyscope ds ii and a spyglass ds controller were used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed in the common bile duct (cbd) on (b)(6) 2020.According to the complainant, during the procedure, the controller was not working.It powers up but will go back to the main screen, and there is no image.Reportedly, a second spyscope ds ii was used; however, this did not resolve the image problem.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.

• Brand Name: SPYGLASS DS DIGITAL CONTROLLER
• Type of Device: LED LIGHT SOURCE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11029492
• MDR Text Key: 222627680
• Report Number: 3005099803-2020-06243
• Device Sequence Number: 1
• Product Code: NTN
• 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,health
• Type of Report: Initial,Followup
• Report Date: 03/25/2021

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: M0054665Z0
• Device Catalogue Number: 4665Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2021
• Initial Date Manufacturer Received: 11/25/2020
• Initial Date FDA Received: 12/17/2020
• Supplement Dates Manufacturer Received: 03/03/2021
• Supplement Dates FDA Received: 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1