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

Model Number M00546650

Device Problems Optical Problem (3001); Appropriate Term/Code Not Available (3191)

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

Event Date 11/02/2021

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 the spyscope ds catheter and spyglass ds digital controller used during the same procedure.It was reported to boston scientific corporation that a spyscope ds catheter and spyglass ds digital controller were used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed in the bile duct on (b)(6) 2021.During the procedure, the spyglass ds controller stopped working in the middle of the case and would not turned on.The controller was rebooted and unplugged the spyscope catheter and reinserted back into the controller and 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 (impact codes): impact code f1001 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 and front panel had cosmetic damage.A functional evaluation noted that the catheter interface contacts was contaminated.The light engine was disassembled.The catheter interface contacts, 32 conductor flex cable, front panel, keypad, top cover, and cover gasket were replaced.The connector socket assembly were cleaned.Light engine calibration was performed and tests were ran.Electrical safety tests were also performed.The unit passed all tests.The reported complaint was confirmed.Upon analysis, the problem is unlikely related to manufacturing, as product analysis identified problems related to use and maintenance and did not identify any manufacturing defect.In addition, during a device history record review conducted by enercon, it was confirmed that the device met all manufacturing specifications.Although the number of procedures/recycles of the unit are unknown, improper handling of the device or wear/tear on internal components over time likely contributed to the event.Therefore, the conclusion code selected for this event 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.Block h11: correction - block h6 (impact code and device code) has been corrected.

Event Description

Note: this report pertains to the spyscope ds catheter and spyglass ds digital controller used during the same procedure.It was reported to boston scientific corporation that a spyscope ds catheter and spyglass ds digital controller were used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed in the bile duct on (b)(6) 2021.During the procedure, the spyglass ds controller stopped working in the middle of the case and would not turned on.The controller was rebooted and unplugged the spyscope catheter and reinserted back into the controller and 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
• 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: 12853802
• MDR Text Key: 285559633
• Report Number: 3005099803-2021-06088
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• 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: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2018
• 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