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

Model Number M00546650

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

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

Event Date 09/20/2021

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 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 bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.Prior to the procedure, the spyscope ds ii catheter was connected into the controller.Shortly after, a series of dots and lines presented on the screen.The controller then randomly switched off and it could not be turned on again.Connections were tested and still 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.

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 bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.Prior to the procedure, the spyscope ds ii catheter was connected into the controller.Shortly after, a series of dots and lines presented on the screen.The controller then randomly switched off and it could not be turned on again.Connections were tested and still 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.The device was not returned.

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 no functional problem found.No errors in the error log.The light engine was disassembled.The catheter interface contacts and connector socket assembly were cleaned.Replaced top cover and cover gasket.Performed light engine calibration and tests.Performed electrical safety tests.The unit passed all tests.The reported event was not confirmed since they were unable to duplicate the customer described problem and was not verified according to product analysis.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 the sfmd, it was confirmed that the device met all manufacturing specifications.Even though the problem was not verified, the unit presented cosmetic damage on the top cover, front panel and the bumper.Based on this information, it is likely that the problem presented was intermittent.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.

• 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: 12636577
• MDR Text Key: 276594475
• Report Number: 3005099803-2021-05310
• Device Sequence Number: 1
• Product Code: NTN
• UDI-Device Identifier: 08714729874348
• UDI-Public: 08714729874348
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K142922
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• 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: 12/16/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2022
• 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