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

Model Number M00546650

Device Problems Improper or Incorrect Procedure or Method (2017); Appropriate Term/Code Not Available (3191)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/27/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a spyglass digital controller was used during a cholangioscopy procedure performed on (b)(6) 2020.According to the complainant, during procedure preparation, it was noticed that the software version of the spyglass digital controller was not properly upgraded.As a result, the controller would not work with the scopes.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 stable.

Manufacturer Narrative

Block h6 (device codes): problem code a27 is being used to capture the reportable event of aborted/cancelled procedure.Block h10: the returned spyglass digital controller was analyzed by enercon technologies, and a visual evaluation noted that there were light scratches on the top cover, two broken rivets on the main housing, and damage to the fan screen/filter.A functional evaluation noted that replacement of the rear fan and filter and a rebuild of the two broken rivets on the main housing were needed.The rear fan and fan filter, top cover, cover gasket, front panel, keypad, main housing, cap pads, conductive gasket, and miscellaneous hardware required for rebuild were replaced.The light engine was disassembled, and the catheter interface contacts and connector socket assembly were cleaned.Light engine calibration and electrical safety tests were performed and all tests passed.No other problems with the device were detected.The reported event was not confirmed.The problem of software not updated is most likely traced to an improper routine or preventative maintenance.Therefore, the probable root cause chosen 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 complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation that a spyglass digital controller was used during a cholangioscopy procedure performed on (b)(6) 2020.During procedure preparation, it was noticed that the software version of the spyglass digital controller was not properly upgraded.As a result, the controller would not work with the scopes.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 stable.

• Brand Name: SPYGLASS DS
• Type of Device: LED LIGHT SOURCE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11039740
• MDR Text Key: 226652435
• Report Number: 3005099803-2020-06213
• Device Sequence Number: 1
• Product Code: NTN
• UDI-Device Identifier: 08714729874348
• UDI-Public: 08714729874348
• Combination Product (y/n): N
• PMA/PMN Number: K142922
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/15/2021

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: 02/02/2021
• Initial Date Manufacturer Received: 11/27/2020
• Initial Date FDA Received: 12/18/2020
• Supplement Dates Manufacturer Received: 02/26/2021
• Supplement Dates FDA Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1