E-LINE 8708518Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04055207020159), received between Sep 6, 2022 and Sep 6, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Failure to Clean Adequately” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 6, 2022Poor Quality Image; Failure to Clean Adequately; Poor Quality Image; Failure to Clean Adequately

  RWMIC REFERENCE COMPLAINT NO. (B)(4). ON (B)(6) 2022, IT WAS REPORTED TO RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC) BY A USER FACILITY REPRESENTATIVE REGARDING PRODUCT ID# 8708.518 SN(B)(4). "THIS URETEROSCOPE WAS JUST REPAIRED, HOWEVER WHEN WE WENT TO USE IT IT WAS BROWN AND CLOUDY. WE WERE UNABLE TO USE THIS URETEROSCOPE TO COMPLETE THE CASE.(RA# FROM PREVIOUS REPAIR- (B)(4))." ADDITIONAL INFORMATION REPORTED BY THE USER FACILITY REPRESENTATIVE: (EMAIL, DATED AUGUST 10, 2022.) "WE HAD TO FLASH THE OTHER LONG URETEROSCOPE, SO IT WAS A 30 MINUTE DELAY." WILL THE DEVICE BE RETURNED? YES. WAS THE DEVICE BEING USED ON A PATIENT WHEN THE REPORTING ISSUE OCCURRED? YES. WAS THERE ANY INJURY OR ILLNESS TO THE PATIENT DUE TO THE REPORTED ISSUE? NO. WAS THERE ANY INJURY OR ILLNESS TO ANY OTHER PERSONNEL DUE TO THE REPORTED ISSUE? NO. DID THE ISSUE CAUSE A DELAY IN THE PROCEDURE BEING PERFORMED? YES. DID THE DELAY PUT THE PATIENT AT RISK? NO. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? YES. WAS THE SCHEDULED PROCEDURE COMPLETED? YES. NEW INFORMATION OBTAINED FROM THE USER FACILITY REPRESENTATIVE: (EMAIL, DATED AUGUST 30, 2022) "I KNOW IT WAS A URETEROSCOPY THAT WAS BEING DONE F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15363763 ↗
• MalfunctionSep 6, 2022Poor Quality Image; Failure to Clean Adequately; Poor Quality Image; Failure to Clean Adequately

  RWMIC REFERENCE COMPLAINT NO. (B)(4). ON AUGUST 10, 2022, IT WAS REPORTED TO RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC) BY A USER FACILITY REPRESENTATIVE REGARDING PRODUCT ID# 8708.518 SN (B)(4). "THIS URETEROSCOPE WAS JUST REPAIRED, HOWEVER WHEN WE WENT TO USE IT WAS BROWN AND CLOUDY. WE WERE UNABLE TO USE THIS URETEROSCOPE TO COMPLETE THE CASE.(RA# FROM PREVIOUS REPAIR- (B)(4))." ADDITIONAL INFORMATION REPORTED BY THE USER FACILITY REPRESENTATIVE: (EMAIL, DATED AUGUST 10, 2022). "WE HAD TO FLASH THE OTHER LONG URETEROSCOPE, SO IT WAS A 30 MINUTE DELAY." WILL THE DEVICE BE RETURNED? YES. WAS THE DEVICE BEING USED ON A PATIENT WHEN THE REPORTING ISSUE OCCURRED? YES. WAS THERE ANY INJURY OR ILLNESS TO THE PATIENT DUE TO THE REPORTED ISSUE? NO. WAS THERE ANY INJURY OR ILLNESS TO ANY OTHER PERSONNEL DUE TO THE REPORTED ISSUE? NO. DID THE ISSUE CAUSE A DELAY IN THE PROCEDURE BEING PERFORMED? YES. DID THE DELAY PUT THE PATIENT AT RISK? NO. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? YES. WAS THE SCHEDULED PROCEDURE COMPLETED? YES. NEW INFORMATION OBTAINED FROM THE USER FACILITY REPRESENTATIVE: (EMAIL, DATED AUGUST 30, 2022). "I KNOW IT WAS A URETEROSCOPY THAT WAS BEING DON

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15363671 ↗