E-LINERecalls & reported problems across all models
Richard Wolf GmbH · 19 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 38
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls
- 0
We found 19 models of E-LINE by Richard Wolf GmbH in the FDA's device registry (GUDID). Together they are named in 38 adverse event reports in the FDA's MAUDE database, received between Apr 20, 2017 and Apr 9, 2026 — classified as 11 injuries, 27 malfunctions.
The most frequently reported specific device problem is “Break” (8 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported E-LINE problems
Device problems
- Break8
- Material Fragmentation7
- Poor Quality Image6
- Material Twisted/Bent3
- No Display/Image3
- Failure to Clean Adequately2
- Insufficient Device Problem Information2
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Consequences Or Impact To Patient13
- No Clinical Signs, Symptoms or Conditions9
- Insufficient Information8
- Foreign Body In Patient4
- Laceration(s)2
- No Known Impact Or Consequence To Patient2
- Unspecified Kidney or Urinary Problem2
- Urethral Stenosis/Stricture2
E-LINE models
19 models, most reported first. Each model has its own page with its reports, recalls and device details.
- E-LINE 86553841RESECTOSCOPE, WORKING ELEMENT7 reports
- E-LINE 8703534Ureteroscope and accessories, flexible/rigid4 reports
- E-LINE 868895ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL3 reports
- E-LINE 8702534Ureteroscope and accessories, flexible/rigid3 reports
- E-LINE 8703524Ureteroscope and accessories, flexible/rigid3 reports
- E-LINE 8654224RESECTOSCOPE, WORKING ELEMENT2 reports
- E-LINE 8702524Ureteroscope and accessories, flexible/rigid2 reports
- E-LINE 8708518Ureteroscope and accessories, flexible/rigid2 reports
- E-LINE 8702517Ureteroscope and accessories, flexible/rigid2 reports
- E-LINE 8424141ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL1 report
- E-LINE 8654204RESECTOSCOPE, WORKING ELEMENT1 report
- E-LINE 8655374RESECTOSCOPE, WORKING ELEMENT1 report
- E-LINE 8702518Ureteroscope and accessories, flexible/rigid1 report
- E-LINE 86500445RESECTOSCOPE, WORKING ELEMENT1 report
- E-LINE 86543742RESECTOSCOPE, WORKING ELEMENT1 report
- E-LINE 86553441RESECTOSCOPE, WORKING ELEMENT1 report
- E-LINE 86880145RESECTOSCOPE, WORKING ELEMENT1 report
- E-LINE 8655384RESECTOSCOPE, WORKING ELEMENT1 report
- E-LINE 8708517Ureteroscope and accessories, flexible/rigid1 report
Recent E-LINE adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionDec 1, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE, THE HOOK ELECTRODE BROKE IN THE PATIENT. THE BROKEN PART WAS TAKEN OUT WITH A DORMIA. THE MEDICAL PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 15-MINUTE DELAY IN SURGERY TIME, WITHOUT INJURY OR ENDANGERMENT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23681723 ↗InjuryJul 7, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT, DURING THE SURGICAL PROCEDURE, THE METAL HOOK BROKE OFF IN THE PATIENT'S BODY. THE MISSING FRAGMENT WENT OUT WITH THE INSTRUMENT AND NO MEDICAL FOLLOW-UP NEEDED. ALSO, IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITHOUT ADDITIONAL UNSCHEDULED MEDICAL MEASURES. THERE WAS NO REPORT OF ANY PATIENT HARM.
Patient problems: Foreign Body In Patient
MAUDE report 22414252 ↗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 ↗InjuryJun 24, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT, DURING THE SURGICAL PROCEDURE, THE METAL HOOK BROKE OFF IN THE PATIENT'S BODY. THE MISSING FRAGMENT WAS IMMEDIATELY SEARCHED FOR IN THE BLADDER BUT COULD NOT BE FOUND. AN X-RAY WAS TAKEN TO IDENTIFY THE FRAGMENT, BUT WITHOUT SUCCESS. AN INDWELLING CATHETER WAS PLACED, AND POSTOPERATIVE FOLLOW-UP INCLUDED A CT SCAN A FEW DAYS LATER AND SURGICAL EXPLORATION TO LOCATE THE FRAGMENT. HOWEVER, IT ULTIMATELY REMAINED UNDETECTABLE.
Patient problems: Foreign Body In Patient
MAUDE report 22318548 ↗InjuryJan 3, 2024No Display/Image; No Display/Image
A DISTRIBUTOR HAS INFORMED RICHARD WOLF GMBH (RWGMBH) OF AN ISSUE REGARDING A URETERORENOSCOPE 12° 8/9.8FR WL 430MM, PART ID: 8703.524, S/N # (B)(6). ACCORDING TO THE RECEIVED INFORMATION, A PLANNED LITHOTRIPSY COULD NOT BE PERFORMED BECAUSE AN IMAGE FAILURE OCCURRED DURING THE APPLICATION. THE PROCEDURE WAS CANCELLED.
Patient problems: Insufficient Information
MAUDE report 18438631 ↗MalfunctionOct 17, 2023Poor Quality Image; Poor Quality Image
THE USER FACILITY HAS INFORMED RICHARD WOLF GMBH OF AN ISSUE REGARDING A URETERORENOSCOPE 12° 8/9.8FR WL 430MM, PART ID: (B)(6), SERIAL NUMBER # (B)(6). ACCORDING TO THE RECEIVED INFORMATION, URS UNDER POOR, CLOUDY VISION. OPERATION WAS TERMINATED EARLY. STONE COULD NOT BE RECOVERED.
Patient problems: Insufficient Information
MAUDE report 17950205 ↗InjuryOct 12, 2023Poor Quality Image; Poor Quality Image
THE USER FACILITY HAS INFORMED RICHARD WOLF GMBH OF AN ISSUE REGARDING A URETERORENOSCOPE 5° 6/7.5FR WL 430MM, PART ID: 8702534, SERIAL NUMBER # (B)(6). SURGERY PLANNED ON AUGUST 5, 2023, RESOLUTION OF PATIENT CASE WITH URETERAL LITHIASIS, URETERAL LITHOTRIPSY SURGERY IS PLANNED USING RICHARD WOLF URETERORENOSCOPE 5° 6/7.5FR. ACCORDING TO THE INITIAL REPORTER, THE PROCEDURE BEGINS, PERCEIVING POOR IMAGE QUALITY AT THE BEGINNING OF THE PROCEDURE, WITH THE PRESENCE OF AN EXTERNAL HALO THAT REDUCES THE FIELD OF VISION, MAKING MANEUVERS WITHIN THE URETER DIFFICULT. AN ATTEMPT IS MADE TO PERFORM LITHOTRIPSY WITH A PNEUMATIC LITHOTRIPTER; DUE TO VISION DIFFICULTIES, IT IS DECIDED TO SUSPEND PROCEDURE AND RESCHEDULE THE CASE UNTIL A NEW WORK ITEM IS AVAILABLE, EXPOSING THE PATIENT AGAIN TO ANOTHER ANESTHETIC EVENT AND ANOTHER HOSPITALIZATION. THERE WAS A TIME DELAY ABOUT 90 MINUTES.
Patient problems: Insufficient Information
MAUDE report 17920799 ↗InjuryJun 30, 2023No Display/Image; Material Twisted/Bent; No Display/Image; Material Twisted/Bent
A DISTRIBUTOR HAS INFORMED RICHARD WOLF GMBH AN ISSUE REGARDING A URETERORENOSCOPE 12° 8/9.8FR WL 430MM, PART ID: 8703524, SERIAL # (B)(6). ACCORDING TO THE RECEIVED INFORMATION, DURING A DIAGNOSTIC URETEROSCOPY/URETERORENOSCOPY (URS) EXAMINATION, THE DISTAL END OF THE SCOPE BENT AND AS A RESULT, THE MONITOR FAILED TO DISPLAY THE IMAGE. CONSEQUENTLY, THE PLANNED SURGERY FOR THE LEFT MID URETERAL AREA WAS CANCELLED.
Patient problems: Insufficient Information
MAUDE report 17239921 ↗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 ↗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 ↗MalfunctionFeb 4, 2022Poor Quality Image; Poor Quality Image
IT WAS REPORTED TO RICHARD WOLF GMBH. "DURING THE FIRST TEST, THE DOCTOR AND THE BIOMEDICAL ENGINEERS CAN SEE THAT THE VISION OF THE URETERO RENOSCOPE IS BAD, THE IMAGE IS BLURRED .THE TREATMENT WAS DELAYED BY THIS INCIDENT OR HAD TO BE DISCONTINUED BECAUSE NO OTHER URETHOSCOPE WAS AVAILABLE. THERE WAS NO RISK TO THE PATIENT OR HEALTH.."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13455526 ↗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 ↗
Other Richard Wolf GmbH products
All Richard Wolf GmbH devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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