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

Model Number	M0067913500
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a020503 is selected to represent the reportable event of packaging seal compromised.
Event or Problem Description
It was reported that during the preparation, the seal of the lithovue flexscope package was found to be broken upon opening.To complete the procedure, a new scope was used.There were no patient complications reported.
Event or Problem Description
It was reported that during the preparation, the seal of the lithovue flexscope package was found to be broken upon opening.To complete the procedure, a new scope was used.There were no patient complications reported.
Additional Manufacturer Narrative
Block h6: device code a020503 is selected to represent the reportable event of packaging seal compromised.Investigation summary: the device was returned to the lab in its packaging.Analysis identified some minor damage to the outside of box.There appeared to be damage on the outer box where the blue coloring was lifted by a piece of tape or some like substance.The box structure was undamaged and contained the pouch with a lithovue scope.The inner pouch was undamaged and completely intact as there are no puncture holes, no creases, and no openings along the sealed edges.The reported complaint was not confirmed as the seal was not compromised.Based on all gathered information and the results of the product analysis, the complaint investigation conclusion code selected is no problem detected, which indicates the device complaint or problem cannot be confirmed.

• Brand Name: LITHOVUE
• Common Device Name: 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19702791
• Report Number: 2124215-2024-38733
• Device Sequence Number: 14377931
• Product Code: FGB
• UDI-Device Identifier: 08714729874805
• UDI-Public: 08714729874805
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K153049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/30/2026
• Device Model Number: M0067913500
• Device Catalogue Number: 791-350
• Device Lot Number: 0033327202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2024
• Supplement Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown