E-LINE 86553841Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04055207028094), received between May 17, 2019 and Apr 9, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (3 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. 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 9, 2026Material Fragmentation

  IT WAS REPORTED THAT THE CERAMIC TIP OF THE SHEATH CAME OFF INSIDE OF THE PATIENT'S BLADDER DURING THE HOLEP (HOLMIUM LASER ENUCLEATION OF THE PROSTATE) PROCEDURE. THE SURGERY WAS PROLONGED BY 15 MINUTES RETRIEVING THE BROKEN PIECE. THE SURGEON WAS ABLE TO REMOVE THE FOREIGN OBJECT WITHOUT ISSUE AND CONFIRMED THAT NO PIECES REMAINED IN THE PATIENT. UPON REVIEW, IT APPEARS THE SHEATH HAS SEPARATED INTO TWO PIECES AND IS NO LONGER ADHERING AS INTENDED. THERE ARE NO REPORTS OF INJURIES, AND THE PLANNED PROCEDURE WAS PERFORMED USING A BACK-UP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24832239 ↗
• MalfunctionJun 26, 2025Material Fragmentation; Material Fragmentation

  THE FACILITY REPORTS THAT AFTER THE CASE WAS COMPLETED, IT WAS FOUND THAT PART OF THE CERAMIC TIP OF THE RESECTOSCOPE'S INNER SHEATH WAS BROKEN, AND A FRAGMENT WAS MISSING. FLUOROSCOPY WAS PERFORMED IN THE ROOM AND THE FRAGMENT WAS IDENTIFIED IN THE PATIENT'S BLADDER. THERE ARE NO REPORTS OF INJURY, BUT THERE WAS A DELAY OF LESS THAN 30 MINUTES, WHICH PUT THE PATIENT AT RISK DUE TO THE PROLONGED ANESTHESIA TIME. IN ADDITION, ADDITIONAL MEDICAL MEASURES WERE NECESSARY.

  Patient problems: Foreign Body In Patient

  MAUDE report 22337722 ↗
• MalfunctionApr 26, 2021Material Separation; Material Separation

  THE PURPOSE OF THIS SUBMISSION IS TO REPORT THE RESULTS OF THE DEVICE INVESTIGATION. ACCORDING TO THE DEVICE INVESTIGATION, RW GMBH VISUALLY INSPECTED THE DEVICE AND ACCORDING TO THEM: "THE INNER SHEATH SHOW CLEAR SIGNS OF INTENSIVE USE: - LASER MARKING (BATCH AND MATERIAL NUMBERS) ARE WORN OFF; - CLEAR SCRATCHES ON THE SURFACE OF THE INNER SHEATH; - INNER SHEATH IS BENT; - COLOR OF THE PLASTIC PART IS BLEACHED. THE TIP OF THE INNER SHEATH WAS BROKEN DUE TO MECHANICAL OVERLOAD SUCH AS A FALL. THE TIP FO THE INNER SHEATH INCLUDES MATERIAL ZIRKONDIOXID ZR02 (3Y-TZP0 BK, THIS CERAMIC LIKE MATERIAL IS SENSITIVE AND BRITTLE WITH LESS FLEXIBILITY. DUE TO INTENSIVE USE, CARELESS HANDLING (SUCH AS SHOCKS) AND AGGRESSIVE CLEANING, THE USEFUL LIFE OF THIS DEVICE CAN BE SHORTENED." THE PROBABLE ROOT CAUSE IS USER ERROR. THE INNER SHEATH 8655.3841 WAS PRODUCED IN 2005. THERE WERE NO ISSUES FOUND WITH THE RESECTOSCOPE THAT WAS SENT IN WITH THE ABOVE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11728915 ↗
• MalfunctionOct 8, 2020Break; Break

  RW (B)(4) WAS NOTIFIED BY THEIR DISTRIBUTOR FOR THE FOLLOWING PRODUCT PROBLEM: IT WAS REPORTED THAT THE PATIENT WAS TAKEN TO THE RECOVERY ROOM AFTER BLADDER TUMOR RESECTOSCOPE PROCEDURE. THE CLEANING STAFF THEN FOUND SHEATH CERAMIC HEAD WAS MISSING. THEY LOOKED FOR CLOTHES AND GARBAGE ROOM BUT COULD NOT FIND THE MISSING CERAMIC HEAD. IMMEDIATELY THEY REPORTED TO THE HEAD NURSE, INFORMED THE SURGEON TO CARRY OUT AN EXAMINATION WITH ULTRASOUND IN THE PATIENT'S BLADDER BUT DID NOT FOUND ANY FOREIGN BODY. THEN, THEY DECIDED TO PERFORM CYSTOSCOPY AND FOUND THE MISSING HEAD INSIDE BLADDER, USING FORCEPS THEY WERE ABLE TO REMOVE IT FROM PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 10652681 ↗
• MalfunctionSep 29, 2020Device Handling Problem; Device Handling Problem

  IT WAS REPORTED TO RICHARD WOLF MEDICAL INSTRUMENTS THAT ON (B)(6) 2016, A TIP BROKE OFF IN A PATIENT, THEY WERE ABLE TO RETRIEVE WITH NO INJURY TO THE PATIENT. ADDITIONAL INFORMATION: (B)(6) CALLED A.G. TO GO OVER EVENT, PIECES FELL OFF IN ONE LARGE PIECE. GRASPER WAS USED TO RETRIEVE PIECES. NO BACKUP DEVICE, BUT STILL USABLE TO COMPLETE CASE (NEAR END OF CASE). NO INJURY TO PATIENT, NO POST PROCEDURE COMPLICATIONS. MINIMAL TIME TO RETRIEVE. MINIMAL RISK. ((B)(6) 2016). WILL THE DEVICE BE RETURNED? YES. WAS THE DEVICE BEING USED ON A PATIENT WHEN THE REPORTED ISSUE OCCURRED? YES. WAS THERE ANY INJURY OR ILLNESS TO PATIENT DUE TO REPORTED ISSUE? NO. WAS THERE ANY INJURY OR ILLNESS TO ANY OTHER PERSONNEL DUE TO REPORTED ISSUE? NO. DID THE ISSUE CAUSE A DELAY IN THE PROCEDURE BEING PERFORMED? NO. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? NO. WAS THE SCHEDULED PROCEDURE COMPLETED? YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10599458 ↗
• MalfunctionJun 28, 2019Break; Break

  ON (B)(6) 2019, A RICHARD WOLF (B)(4) BECAME AWARE OF THE FOLLOWING REPORT: ACCORDING TO THE SURGEON, DURING A "TUR" SURGERY, THE CERAMIC TIP ENDED UP INSIDE THE BLADDER CAVITY. THE SURGEON HAD TO USE A LOOP TO PUT TOGETHER A HOOK AND DRAG IT THROUGH THE URETHRA, UNTIL THE NAVICULAR FOSSA, WHERE THE INSTRUMENT ENDED UP GETTING STUCK. AS A RESULT, THE SURGEON HAD TO FRAGMENT THE TIP WITH A STRAIGHT HALSTED CLAMP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8744731 ↗
• MalfunctionMay 17, 2019Break; Break

  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 O

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8621178 ↗