MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LITHOVUE SYSTEM WORKSTATION; URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number 801-000

Device Problems No Display/Image (1183); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 05/07/2021

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 mdr will be filed.

Event Description

It was reported to boston scientific corporation that a lithovue touch pc was used on (b)(6) 2021.During preparation, the monitor was not showing any image.The screen only showed a black screen.The procedure was cancelled due to this event.There were no reported patient complications as a result of this event.

• Brand Name: LITHOVUE SYSTEM WORKSTATION
• Type of Device: URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue; attn: return products; st. paul MN 55112
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 11897639
• MDR Text Key: 253220005
• Report Number: 3005099803-2021-02516
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 08714729974789
• UDI-Public: 08714729974789
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K153049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 801-000
• Device Catalogue Number: 801-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2020
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1