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

Model Number	F88
Medical Device Problem Codes	Material Puncture/Hole (1504); Gas/Air Leak (2946)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing records for subject device were reviewed.Device passed all in-process and final inspection checks.No manufacturing deviations were identified.Subject device was received and successfully decontaminated.Visual inspection identified breach in bending rubber.Device evaluation has been completed.Leak test confirmed air leakage consistent with reported complaint.Working channel integrity was assessed by fluid flush with distal tip blocked, fluid leaked from bending rubber breach, confirming rubber perforation.Breach observed to be located on side adjacent to light guide bundle.Additional visual / functional inspection revealed the following: light guide fiber damage with its sheath showing signs of thermal damage, damaged uv adhesive and suture near bending rubber breach, suture fusing at ends (thermal damage pattern), normal video sensor function but with diminished lumen output as compared to at manufacture.Physical evidence suggests laser activation within working channel perforated channel wall, damaged light guide bundle, and breached bending rubber.Thermal suture damage, light fibre sheath damaqe pattern, and breach location are consistent with laser firing inside channel during use.There are zero (0) prior reports of leak attributed to laser activation within working channel.This is the first occurrence.Risk analysis had previously identified accidental laser firing within device channel risk.Ifu contains warning: "when using laser probes, make sure the laser power is not activated until the probe tip has fully emerged from the working channel, is visible on the surgical display monitor, and the surgical site is clearly identifiable.Activating the laser while the probe is still in the working channel could result in patient injury and damage the flexible ureteroscope." existing warning deemed adequate.Continuous complaint monitoring will be performed with trending review.
Event or Problem Description
It was reported that the subject device did not pass the leak test, leak failure was near the distal tip.Device was used once in a ureteroscopy (with laser) procedure prior to failure.There is no report of patient involvement.

• 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: 24907288
• Report Number: 3038613058-2026-00001
• Device Sequence Number: 13243959
• Product Code: FGB
• UDI-Device Identifier: 08881300750091
• UDI-Public: 08881300750091
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/17/2026

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 Model Number: F88
• Device Catalogue Number: 0502388100
• Device Lot Number: E/LOTFG-102278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown