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

Model Number M00546650

Device Problem Failure to Power Up (1476)

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

Event Date 02/01/2023

Event Type  malfunction  

Manufacturer Narrative

The exact date of the event is unknown.The reporter did not provide event date, (b)(6)2023, was chosen as a best estimate based on the date that the manufacturer became aware of the event.Imdrf impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.

Event Description

It was reported to boston scientific corporation that spyglass digital controller was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.During the procedure, the device was unable to power up.The procedure was aborted and rescheduled due to this event.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block b3 (date of event): the exact date of the event is unknown.The reporter did not provide event date, february 01, 2023, was chosen as a best estimate based on the date that the manufacturer became aware of the event.Block h6: imdrf impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.Block h10: the returned spyglass digital controller was analyzed by enercon technologies, the top cover and front panel was damaged.The rear y/c video outputs badly worn out.Product analysis was not unable to replicate customer complaint.The spyglass ds controller ran through initial testing and error log download without problem.No functional problems were found.Per the evaluation conducted by enercon technologies, the reported event was not confirmed.The number of procedures/recycles of the unit, handling during use and reprocessing over time are unknown, therefore is probable that problems are intermittent and are traced to improper routine or preventative maintenance.Based on all gathered information, the most probable root cause for this investigation is cause traced to maintenance.

Event Description

It was reported to boston scientific corporation that spyglass digital controller was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.During the procedure, the device was unable to power up.The procedure was aborted and rescheduled due to this event.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
• 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: 16624668
• MDR Text Key: 312106031
• Report Number: 3005099803-2023-01318
• Device Sequence Number: 1
• Product Code: NTN
• UDI-Device Identifier: 08714729874348
• UDI-Public: 08714729874348
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/12/2023

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
• Device Lot Number: 1931600208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2023
• Initial Date Manufacturer Received: 02/28/2023
• Initial Date FDA Received: 03/27/2023
• Supplement Dates Manufacturer Received: 04/19/2023
• Supplement Dates FDA Received: 05/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2019
• 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