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

Model Number M0067913500

Device Problems Defective Device (2588); Physical Resistance/Sticking (4012)

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

Event Date 06/24/2020

Event Type  malfunction  

Event Description

Surgeon requested the lithovue digital flexible single-use ureteroscope for use.The ureteroscope device was deflected in the kidney and would not straighten.The device should be able to deflect in both directions and straighten.Surgeon was concerned that it could have hurt the kidney, however, stated that he performed c-arm images that showed everything was ok with the kidney.The product/device was saved and bagged for evaluation.There was laser lithotripsy performed during the procedure.Manufacturer response for lithovue digital flexible single-use ureteroscope, lithovue digital flexible single-use ureteroscope (per site reporter).Awaiting rma from vendor to return product.

• Brand Name: LITHOVUE
• Type of Device: URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10270307
• MDR Text Key: 198710831
• Report Number: 10270307
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/10/2020,07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0067913500
• Device Lot Number: 25497443
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/10/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25915 DA