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

Model Number M0054665Z0

Device Problems Connection Problem (2900); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/11/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The returned spyglass ds digital controller was analyzed by enercon technologies.The analysis found that the top cover and rear bumper were damaged.The front panel of the device was scuffed.A functional assessment was performed and error logs indicated errors accessing a peripheral device.The unit was failing to connect and recognize an inserted scope catheter.Additionally, catheter interface contacts and socket assembly has white residue from end users cleaning solution.The reported event was confirmed.It is likely that the catheter interface contacts and socket assembly had white residue from end users cleaning solution, causing the reported device connection issue.A labeling review was performed and found the following cleaning instructions: disconnect the power cord before cleaning or disinfecting the unit.Use a 15 to 70 percent isopropyl alcohol in purified water solution and a cloth to clean the controller enclosure, front panel, and power cable.Do not allow fluids to enter the enclosure, power cable connections, catheter cable receptacle, or component/accessory connections.Therefore, the most probable cause of this complaint is failure to follow instructions, which indicates problems traced to the user not following the manufacturer's instructions.A device history record (dhr) review was performed and 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 digital controller was used during a procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the controller kept disconnecting and losing connection to the scope.They tried two different scopes, but the controller kept disconnecting.The procedure was rescheduled due to this event.There were no patient complications reported as a result of this event.

• Brand Name: SPYGLASS DS DIGITAL CONTROLLER
• 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: 10095851
• MDR Text Key: 194000700
• Report Number: 3005099803-2020-02047
• Device Sequence Number: 1
• Product Code: NTN
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0054665Z0
• Device Catalogue Number: 4665Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2015
• 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