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

Model Number M0067913600

Device Problem Unsealed Device Packaging (1444)

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

Event Date 08/24/2018

Event Type  malfunction  

Manufacturer Narrative

The device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 on august 23, 2018 that a lithovue flexscope was used during a procedure performed on an unknown date.According to the complainant, during unpacking, the package was not completely sealed and the lithovue scope inside was considered to be unsterile.Boston scientific has been unable obtain additional information regarding the circumstances surrounding this event to date.Should additional relevant details become available, a supplemental report will be submitted.

• Brand Name: LITHOVUE
• 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; 780 brookside drive; ,; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 7886946
• MDR Text Key: 120710691
• Report Number: 3005099803-2018-60492
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 08714729874812
• UDI-Public: 08714729874812
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/29/2020
• Device Model Number: M0067913600
• Device Catalogue Number: 69190
• Device Lot Number: 0022446311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Date Manufacturer Received: 08/23/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/30/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1