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

Model Number M00546650

Device Problems Failure to Power Up (1476); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/23/2020

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 ds controller was used during diagnostic cholangioscopy with spy glass procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the spyglass ds controller light went on and then it went off.They tried to reconnect but still it did not work.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 (device codes): problem code 3191 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: the returned spyglass ds controller was analyzed by enercon technologies, and a visual evaluation noted that the front panel was cracked at the socket opening.It was also noted that something was loose inside the unit.Product testing was performed.A rebuild was required.The light engine was disassembled, the connector socket assembly and catheter interface contacts were cleaned.The unit housing, front panel, keypad, 32 conductor cable, gap pads, conductive pad, top cover, cover gasket, rear bumper and hardware associated with a rebuild were all replaced.Upon analysis of the returned device, it is possible the reported event could be related to wear or tear on the console (manufacture date of the unit is (b)(6) 2016).The event could have happened due to prolonged and extended use of the device.Therefore, the complaint investigation conclusion code selected is cause traced to maintenance, which indicates that the problem is 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.

Event Description

It was reported to boston scientific corporation that a spyglass ds controller was used during diagnostic cholangioscopy with spy glass procedure performed on (b)(6)2020.According to the complainant, during the procedure, the spyglass ds controller light went on and then it went off.They tried to reconnect but still it did not work.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
• MDR Report Key: 10282803
• MDR Text Key: 199754731
• Report Number: 3005099803-2020-02800
• 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: 09/24/2020

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: 08/13/2020
• Initial Date Manufacturer Received: 06/23/2020
• Initial Date FDA Received: 07/16/2020
• Supplement Dates Manufacturer Received: 09/01/2020
• Supplement Dates FDA Received: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1