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

Model Number M00546650

Device Problem Unexpected Shutdown (4019)

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

Event Date 05/01/2022

Event Type  malfunction  

Event Description

Note: this report pertains to a spy ds controller and a spyscope ds ii used during the same procedure.It was reported to boston scientific corporation that a spy ds controller and a spyscope ds ii were used during and endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.During the procedure, they wanted to use spy and the generator was not working properly.The lights weren't coming on when the catheter was being plugged in.The procedure was not completed due to this event and the patient has to come back for another procedure.There were no patient complications reported as a result of this event.

Manufacturer Narrative

(date of event): the exact date of the event is unknown.The provided event date (b)(6) 2022.Was chosen as a best estimate based on the date that the manufacturer became aware of the event.(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.

Manufacturer Narrative

Block b3 (date of event): the exact date of the event is unknown.The provided event date 01may2022 was chosen as a best estimate based on the date that the manufacturer became aware of the event.Block h6 (impact codes): impact code f05 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 y/c video outputs was worn and the top cover had a finish damage.A functional evaluation noted that there is no functional problem with the controller.Per the evaluation conducted by enercon technologies, the reported event of unexpected shutdown could not be duplicated.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 gathered information, the most probable root cause is cause traced to 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.

Event Description

Note: this report pertains to a spy ds controller and a spyscope ds ii used during the same procedure.It was reported to boston scientific corporation that a spy ds controller and a spyscope ds ii were used during and endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.During the procedure, they wanted to use spy and the generator was not working properly.The lights were not coming on when the catheter was being plugged in.The procedure was not completed due to this event and the patient has to come back for another procedure.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: 14515471
• MDR Text Key: 296783766
• Report Number: 3005099803-2022-02956
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/21/2022

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: 05/18/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2022
• Initial Date FDA Received: 05/26/2022
• Supplement Dates Manufacturer Received: 06/28/2022
• Supplement Dates FDA Received: 07/21/2022
• 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