MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORP. LITHOVUE; URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Catalog Number M0067913500

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/04/2020

Event Type  malfunction  

Event Description

Boston scientific disposable scope operating failure during urology procedure.Scope broke during patient operation.A new one of the same scope was opened immediately to continue procedure.Broke disposable scope was put back into it's packaging and a red contamination bag for return and possible credit from manufacture.The scope was removed from service.A new scope was opened and used.These scopes are disposable.The broken one was saved to return to the company.Operating room staff state the product just stopped working for no apparent reason.

• Brand Name: LITHOVUE
• Type of Device: URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORP.
• MDR Report Key: 10384496
• MDR Text Key: 202415731
• Report Number: MW5095965
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: M0067913500
• Device Lot Number: 25597505
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 118