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

Model Number M00546650

Device Problem Connection Problem (2900)

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

Event Date 03/10/2022

Event Type  malfunction  

Event Description

Note: this report pertains to two spyscope ds ii and spyglass ds controller used during the same procedure.It was reported to boston scientific corporation that two spyscope ds ii and spyglass ds controller were used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed in the common bile duct on (b)(6) 2022.During the procedure, artefacts was seen on the screen when using the spyglass ds controller.They tried two different batches of spyscope ds ii; however, the problem was not resolved.They thought that the problem was the base of the plug of spyglass ds controller, that the contact between the spyscope and the spyglass plug was very bad and when they moved the spyscope in the plug the image was better.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be ok.

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 two spyscope ds ii and spyglass ds controller used during the same procedure.It was reported to boston scientific corporation that two spyscope ds ii and spyglass ds controller were used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed in the common bile duct on march 10, 2022.During the procedure, artefacts was seen on the screen when using the spyglass ds controller.They tried two different batches of spyscope ds ii; however, the problem was not resolved.They thought that the problem was the base of the plug of spyglass ds controller, that the contact between the spyscope and the spyglass plug was very bad and when they moved the spyscope in the plug the image was better.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be ok.

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 a finish damage to top cover and retention tongue was discolored.A functional evaluation noted that the unit has fluid ingress and the light emitting diode's (led's) was damaged.Per the evaluation conducted by enercon technologies, the reported event was confirmed.A risk review confirms this is not a new or unanticipated event.As per report attached, 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.Based on all gathered information, the most probable root cause of 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 this event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.A search of the complaint database not performed because this investigation did not identify a potential process, design, or manufacturing related issue for this 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: 14013671
• MDR Text Key: 288591302
• Report Number: 3005099803-2022-01854
• Device Sequence Number: 1
• Product Code: NTN
• UDI-Device Identifier: 08714729874348
• UDI-Public: 08714729874348
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2015
• 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