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

Model Number M0054665Z0

Device Problems Appropriate Term/Code Not Available (3191); Unexpected Shutdown (4019)

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

Event Date 09/02/2021

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 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 catheter and a spyglass ds controller used during the same procedure.It was reported to boston scientific corporation that three spyscope ds ii catheter and a spyglass ds controller were used during an endoscopic retrograde cholangiopancreatography (ercp) with spyglass and electrohydraulic lithotripsy (ehl) procedure performed in the bile duct on (b)(6) 2021.During the procedure, the image of the spyscope ds ii was lost approximately 2 minutes into the procedure when heavy irrigation was performed in preparation for ehl.A second spyscope ds ii catheter was used and the image was also lost approximately 5 minutes into the procedure during ehl and irrigation.The spyscope ds ii catheter was unplugged and connected back into the controller; however, the problem was not resolved.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.

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 ds digital controller was analyzed by enercon technologies, and a visual evaluation noted that the top cover was damage.The light engine was disasembled.The catheter interface contacts and connector socket assembly were cleaned.The top cover, top cover gasket, front panel and keypad were replaced.Light engine calibration was performed and tests were ran.Electrical safety tests were also performed.The unit passed all tests.The reported event was not confirmed.Upon analysis, the returned device was unable to replicate the problem or identify any problem that could caused or contributed the reported event.A device history record (dhr) review was conducted and found that there were no deviations that could have contributed to the reported event and that the product met all manufacturing specifications.A review of the risk documentation confirms that the problem is not a new or unanticipated event.The design failure modes and effects analysis (dfmea) lists mitigations in place that control design features through specification and manufacturing inspection, and therefore it is unlikely a problem with the design of the device.Based on all gathered information, the investigation concluded that the most probable root cause of this complaint is no problem detected.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: correction: block b5 (describe event or problem) has been corrected.

Event Description

Note: this report pertains to two spyscope ds ii catheter and a spyglass ds controller used during the same procedure.It was reported to boston scientific corporation that two spyscope ds ii catheter and a spyglass ds controller were used during an endoscopic retrograde cholangiopancreatography (ercp) with spyglass and electrohydraulic lithotripsy (ehl) procedure performed in the bile duct on (b)(6) 2021.During the procedure, the image of the spyscope ds ii was lost approximately 2 minutes into the procedure when heavy irrigation was performed in preparation for ehl.A second spyscope ds ii catheter was used and the image was also lost approximately 5 minutes into the procedure during ehl and irrigation.The spyscope ds ii catheter was unplugged and connected back into the controller; however, the problem was not resolved.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.

• 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: 12533457
• MDR Text Key: 273359988
• Report Number: 3005099803-2021-04991
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 11/09/2021

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: 09/21/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/03/2021
• Initial Date FDA Received: 09/27/2021
• Supplement Dates Manufacturer Received: 10/18/2021
• Supplement Dates FDA Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2017
• 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