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

Model Number M0054665Z0

Device Problems Poor Quality Image (1408); Defective Device (2588); Appropriate Term/Code Not Available (3191); Unexpected Shutdown (4019)

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

Event Date 10/29/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon 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 a spyscope ds ii catheter and a spyglass ds controller used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii catheter and a spyglass ds controller were used during an endoscopic retrograde cholangiopancreatography (ercp) with spyglass and stone lithotripsy procedure performed on (b)(6) 2021.During preparation, the nurse team turned on the spy controller prior to opening the spyscope device.They had problems with getting the controller to start.They noticed a loud hum and the fan was making loud noise.The nurse unplugged and plugged back in the controller and turned it on.They opened a spyscope and plugged it into the controller, poor imaging was noticed.The image was dark and had green spots in the background.The procedure was aborted and two plastic stents were placed in the patient.The lithotripsy procedure was rescheduled for a later date approximately 4-6 weeks.There were no patient complications reported as a result of this event.

Event Description

Note: this report pertains to a spyscope ds ii catheter and a spyglass ds controller used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii catheter and a spyglass ds controller were used during an endoscopic retrograde cholangiopancreatography (ercp) with spyglass and stone lithotripsy procedure performed on (b)(4) 2021.During preparation, the nurse team turned on the spy controller prior to opening the spyscope device.They had problems with getting the controller to start.They noticed a loud hum and the fan was making loud noise.The nurse unplugged and plugged back in the controller and turned it on.They opened a spyscope and plugged it into the controller, poor imaging was noticed.The image was dark and had green spots in the background.The procedure was aborted and two plastic stents were placed in the patient.The lithotripsy procedure was rescheduled for a later date approximately 4-6 weeks.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6 (device codes): impact code f05 is being used to capture the reportable event of aborted/cancelled procedure.Block h10: the returned spy ds controller was analyzed by enercon technologies, and a visual evaluation noted that the top cover had finish defects, the front panel screen printing wore off, and the y/c video outputs were badly worn.A functional evaluation noted that there was significant dust ingress/damage.Both intake fans were significantly blocked with fibrous material.Light engine light emitting diodes (leds) were damaged.The obsolete lighting system had no replacement parts, so the unit was scrapped.No other problems with the device were noted.The reported event was confirmed.Due to the condition of the unit, it had to be scrapped.Therefore, based on that information, the conclusion code selected is end of life problem identified, which indicates problems traced to the device reaching its end of life.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 complaints exist for the specified lot.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

• 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
• 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: 12821560
• MDR Text Key: 285369680
• Report Number: 3005099803-2021-05934
• Device Sequence Number: 1
• Product Code: NTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142922
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• 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: 11/15/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2015
• 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