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

Model Number M00546650

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

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

Event Date 06/21/2021

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 a spyscope ds and a spyglass ds controller used during the same procedure.It was reported to boston scientific corporation that a spyscope ds and a spyglass ds controller were used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with cholangioscopy and electrohydraulic lithotripsy (ehl) procedure performed on (b)(6) 2021.During the procedure, as soon as they plugged the catheter in, the controller turns on and off.The spyscope ds was disconnected and reconnected to the controller, but the problem was not resolved.The procedure was rescheduled and they used another spy catheter a few days later to finish what was needed to do for the patient.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 had cosmetic damaged.A functional evaluation noted that there were no errors in the error log and no functional problems found.The light engine was disassembled.The catheter interface contacts and connector socket assembly were cleaned.The front panel, keypad, top cover, rear bumper and cover gasket were replaced.Re-torqued all hardware items where necessary.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 not confirmed.Upon analysis, there were no errors in the error log and no functional problems found.A risk review confirms this is not a new or unanticipated event.During a device history record review conducted by enercon it was confirmed that the device met all manufacturing specifications.Based on all gathered information, the most probable root cause of this event 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.

Event Description

Note: this report pertains to a spyscope ds and a spyglass ds controller used during the same procedure.It was reported to boston scientific corporation that a spyscope ds and a spyglass ds controller were used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with cholangioscopy and electrohydraulic lithotripsy (ehl) procedure performed on (b)(6), 2021.During the procedure, as soon as they plugged the catheter in, the controller turns on and off.The spyscope ds was disconnected and reconnected to the controller, but the problem was not resolved.The procedure was rescheduled and they used another spy catheter a few days later to finish what was needed to do for the patient.There were no patient complications reported as a result of this event.

• 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: 12193471
• MDR Text Key: 262429517
• Report Number: 3005099803-2021-03578
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/31/2021

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: 07/07/2021
• Initial Date Manufacturer Received: 06/22/2021
• Initial Date FDA Received: 07/19/2021
• Supplement Dates Manufacturer Received: 08/11/2021
• Supplement Dates FDA Received: 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 21 YR