E-LINE 8702517Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04055207063309), received between May 31, 2022 and May 31, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• InjuryMay 31, 2022Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  IT WAS REPORTED TO RICHARD WOLF THAT "WHEN SCOPE AND BASKET WERE BEING REMOVED FROM THE PATIENT, PART OF THE URETER WAS REMOVED TOO." 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? YES. 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? NO. DID THE DELAY PUT THE PATIENT AT RISK? UNKNOWN. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? YES. WAS THE SCHEDULED PROCEDURE COMPLETED? YES. ADDITIONAL DETAILS ABOUT THE ADVERSE EVENT: WHAT IS THE CURRENT STATUS OF THE PATIENT? PATIENT IS BEING FOLLOWED UP AT (B)(6). WAS THE URETER REPAIRED? NO, URETER WAS NOT REPAIRED. IT WAS DISSECTED IN TWO PLACES. PATIENT CURRENTLY HAS A NEPHROTUBE AND IS WAITING FOR FOLLOW UP AT (B)(6). WHAT KIND OF PROCEDURE WAS IT? URETEROSCOPY, STONE REMOVAL WITH LASER AND BASKETING. WAS THERE ANY PROBLEM AT THE BEGINNING OF THE PROCEDURE WHEN THEY LED THE SCOPE INTO THE URETER? NO. WAS IT ALREADY TIGHT? AS THE DR WAS INSERTING THE SCOPE IT WENT IN WITH NO PROBLEMS. SHE NOTICED

  Patient problems: Insufficient Information; Laceration(s); Unspecified Kidney or Urinary Problem; Urethral Stenosis/Stricture

  MAUDE report 14552168 ↗
• InjuryMay 31, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO RICHARD WOLF THAT "WHEN SCOPE AND BASKET WERE BEING REMOVED FROM THE PATIENT, PART OF THE URETER WAS REMOVED TOO. 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? YES. 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? NO. DID THE DELAY PUT THE PATIENT AT RISK? UNKNOWN. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? YES. WAS THE SCHEDULED PROCEDURE COMPLETED? YES. ADDITIONAL DETAILS ABOUT THE ADVERSE EVENT: WHAT IS THE CURRENT STATUS OF THE PATIENT? PATIENT IS BEING FOLLOWED UP AT U OF M. WAS THE URETER REPAIRED? NO, URETER WAS NOT REPAIRED. IT WAS DISSECTED IN TWO PLACES. PATIENT CURRENTLY HAS A NEPHROTUBE AND IS WAITING FOR FOLLOW UP AT U OF M. WHAT KIND OF PROCEDURE WAS IT? URETEROSCOPY, STONE REMOVAL WITH LASER AND BASKETING. WAS THERE ANY PROBLEM AT THE BEGINNING OF THE PROCEDURE WHEN THEY LED THE SCOPE INTO THE URETER? NO. WAS IT ALREADY TIGHT? AS THE DR WAS INSERTING THE SCOPE IT WENT IN WITH NO PROBLEMS. SHE NOTICED A

  Patient problems: Laceration(s); Unspecified Kidney or Urinary Problem; Urethral Stenosis/Stricture

  MAUDE report 14552095 ↗