E-LINE 86543742Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04055207028049), received between May 17, 2019 and May 17, 2019 — classified as 1 malfunction.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 17, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON APRIL 19, 2019 THE USER FACILITY REPORTED THE FOLLOWING TO RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC): AN INCIDENT DID OCCUR ON A PATIENT DURING THE CASE. THE CASE FINALLY STARTED 75MINS DELAYED AND THE DOCTOR USED THE WOLF PIRANHA GREEN LIGHT LASER TRAY FOR APPROXIMATELY 1HR 45MINS USING 338,167 JOULES SCOPE SET WORKED EXTREMELY WELL WITH 26FR OUTER SHEATH AND 24FR INNER SHEATH BUT WHEN IT WAS TIME TO SWITCH TO MORCELLATOR PART OF THE CASE THE DOCTOR NOTICE AN OBJECT IN THE BLADDER AND USED A GRASPER TO RETRIEVE THE OBJECT. THE OBJECT WAS A PIECE OF BROKEN OFF DEBRIS FROM THE DISTAL TIP OF THE 24FR INNER LASER SHEATH. THE DOCTORS TECHNIQUE WAS VERY GOOD SO I DID NOT NOTICE ANY MISHANDLING OF THE EQUIPMENT. I NOTIFIED THE OPERATING ROOM CHARGE NURSE, MS. (B)(6) OF THE DAMAGE WHICH OCCURED TO THE WOLF 24FR INNER SHEATH AND THAT THEY WOULD BE LIABLE FOR THE COST OF REPAIR. THE CASE WAS COMPLETED WITHOUT INJURY TO THE PATIENT OR STAFF. WILL THE DEVICE BE RETURNED? YES. WAS THE DEVICE BEING USED DURING A PROCEDURE WHEN THE ISSUE OCCURRED? YES. SPECIFICALLY, WAS THE DEVICE BEING USED ON A PATIENT WHEN THE ISSUE OCCURRED? YES. WAS THERE ANY INJURY OR ILLNESS TO PATIENT OR OT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8621180 ↗