MAUDE Adverse Event Report: MEDIMAGING INTEGRATED SOLUTION INC VERSAVUE; Cystoscope and accessories, flexible/rigid

Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blocks d4 and h4: the complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.Block h6: device code a020102 is being used to capture the event of scope working channel damaged or defective.Block h11: detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that during a renal stone procedure using a versavue single-use device scope, the physician observed a tumor while completing cystoscopy for wire placement.The physician introduced a biopsy forceps; however, when the forceps were opened, they penetrated through the side of the scope.There were no patient complications, and the procedure was successfully completed using a replacement versavue scope.

• Brand Name: VERSAVUE
• Common Device Name: Cystoscope and accessories, flexible/rigid
• Manufacturer (Section D): MEDIMAGING INTEGRATED SOLUTION INC; 3f., no.24-2, industry e.; rd. iv, hsinchu science park; hsinchu city 30077 ; TW 30077
• Manufacturer (Section G): MEDIMAGING INTEGRATED SOLUTION INC; 3f no 24 2 industry e; rd iv hsinchu; hsinchu city 30009 ; TW 30009
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 23644976
• Report Number: 2124215-2025-86221
• Device Sequence Number: 9858992
• Product Code: FAJ
• UDI-Device Identifier: 04719872715146
• UDI-Public: (01)04719872715146
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/25/2025

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 11/25/2025
• 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