MAUDE Adverse Event Report: MEDIMAGING INTEGRATED SOLUTION INC VERSAVUE; CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Lot Number	0024291101
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a percutaneous nephrolithotomy (pcnl), a non-boston scientific scope to place a wire from the kidney to the bladder, and a versavue device was also used.When attempting to remove the versavue, it was noted that the device became stuck in the scope's sheath and broke apart.The sheath was removed, and the procedure had to be completed with an alternative method.
Additional Manufacturer Narrative
Block h6: impact code a0413 is being used to capture the reportable event of unexpected material separation.
Additional Manufacturer Narrative
Block h6: impact code a0413 is being used to capture the reportable event of unexpected material separation.Block h11: the returned versavue device was analyzed, and functional testing confirmed that the outer diameter met specifications.Visual inspection revealed that the bending cell section of the returned scope was broken.X-ray imaging and additional testing did not identify any other abnormalities.Review of the provided media indicated material separation, as the images showed that the shaft cells had become separated.However, based on the images alone, it was not possible to confirm whether the device was difficult to remove or if entrapment occurred.Disassembly of the returned product confirmed a broken section of the bending cell, but no further abnormalities were found upon x-ray review.The likely cause appears to be incompatibility between the versavue device and the non-boston scientific scope.The customer reported that no dilator or guidewire was used during assembly, although resistance was noted during the process.Since the customer did not provide the specific non-boston scientific scope model or details regarding usage conditions and storage environment, further verification of the issue was not possible.This event is considered an isolated quality incident.Based on the provided images, only the "material separation" complaint code is confirmed, as shown in the photos.The codes for "difficult to remove" and "entrapment of device or device component" cannot be confirmed because additional compatibility testing could not be performed.It is also possible that the reported resistance was due to tortuous anatomy; however, no evidence is available to support this.As an expected or random component failure was identified without any design or manufacturing defect, the most probable cause for this complaint is cause traced to component failure.Block h11: 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 percutaneous nephrolithotomy (pcnl), a non-boston scientific scope to place a wire from the kidney to the bladder, and a versavue device was also used.When attempting to remove the versavue, it was noted that the device became stuck in the scope's sheath and broke apart.The sheath was removed, and the procedure had to be completed with an alternative method.

• 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, 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: 22290278
• Report Number: 2124215-2025-39663
• Device Sequence Number: 21063252
• Product Code: FAJ
• UDI-Device Identifier: 04719872715047
• UDI-Public: (01)04719872715047
• 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,Followup
• Report Date (Section B): 11/13/2025

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
• Device Expiration Date: 07/19/2025
• Device Lot Number: 0024291101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2025
• Supplement Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2024
• 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