MAUDE Adverse Event Report: SG ENDOSCOPY PTE LTD F88 URE-SD FLEXIBLE URETEROSCOPE

Model Number	F88
Medical Device Problem Codes	Gas/Air Leak (2946); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Design history records review was performed, there was no infomration that suggested that the manufacturing process had any relation to the reported event.The device was manufactured, inspected and released in accordance with established procedures and acceptance criteria.Device has been received and investigations are ongoing.A follow-up report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
It was reported that the subject device failed leak test during reprocessing.There was no reports of patient involvement.
Additional Manufacturer Narrative
This follow-up report is submitted to provide the results of the investigation conducted on the subject device.The reported complaint was confirmed.The device failed the manual leak test, and immersion in water verified the presence of a leak originating from the bending rubber near the distal tip.A visual inspection under 10× magnification identified a small incision measuring approximately 0.5 mm on the bending rubber.To facilitate further evaluation, the bending rubber was removed.Upon removal, it was observed that the underlying bending section segment located beneath the incision had rotated out of its intended position.This rotational displacement caused certain metallic components to protrude outward.The protrusion was determined to be the cause of the bending rubber damage, resulting from increased mechanical stress during bending section articulation and repetitive abrasive cutting interaction with the rubber material.A segment dislocation of this nature is considered highly unlikely to occur under normal use conditions.Based on the available evidence, the root cause of the rotational dislocation was attributed to user error, specifically the application of excessive rotational force to the bending rubber or distal tip during device manipulation.

• Brand Name: F88 URE-SD FLEXIBLE URETEROSCOPE
• Common Device Name: FLEXIBLE URETEROSCOPE
• Manufacturer (Section D): SG ENDOSCOPY PTE LTD; 77 loyang way; singapore, singapore 50876 5; SN 508765
• Manufacturer (Section G): FONG'S ENGINEERING AND MANUFACTURING; 79 loyang way; singapore, 50876 6; SN 508766
• Manufacturer Contact: nichiolas lau ; 77 loyang way; singapore, singapore 50876-5 ; SN 508765
• MDR Report Key: 23528886
• Report Number: 3038613058-2025-00007
• Device Sequence Number: 9083679
• Product Code: FGB
• UDI-Device Identifier: 08881300750091
• UDI-Public: 08881300750091
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2025

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
• Device Model Number: F88
• Device Catalogue Number: 0502388100
• Device Lot Number: E/LOTFG-101736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/10/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown