SHARK/S-LINERecalls & reported problems across all models
Richard Wolf GmbH · 11 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 48
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls
- 0
We found 11 models of SHARK/S-LINE by Richard Wolf GmbH in the FDA's device registry (GUDID). Together they are named in 48 adverse event reports in the FDA's MAUDE database, received between Mar 10, 2017 and Jul 2, 2026 — classified as 9 injuries, 39 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (13 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 SHARK/S-LINE problems
Device problems
- Material Fragmentation13
- Break7
- Melted5
- Thermal Decomposition of Device5
- Detachment of Device or Device Component4
- Material Separation3
- Overheating of Device3
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- Foreign Body In Patient9
- Insufficient Information9
- Device Embedded In Tissue or Plaque4
- No Consequences Or Impact To Patient4
- Burn, Thermal2
- Electric Shock2
- Twitching2
SHARK/S-LINE models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SHARK/S-LINE 46221333ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL10 reports
- SHARK/S-LINE 46221313ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL9 reports
- SHARK/S-LINE 8622131ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL6 reports
- SHARK/S-LINE 8108232ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL4 reports
- SHARK/S-LINE 8622133ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL4 reports
- SHARK/S-LINE 46241313ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL4 reports
- SHARK/S-LINE 46300243ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL4 reports
- SHARK/S-LINE 46222513ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL3 reports
- SHARK/S-LINE 46300223ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL2 reports
- SHARK/S-LINE 8108252ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL1 report
- SHARK/S-LINE 46221313USHYSTEROSCOPE (AND ACCESSORIES)1 report
Recent SHARK/S-LINE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJul 2, 2026Material Deformation
ACCORDING TO THE REPORT, A CONCEALED BLADDER RUPTURE OCCURRED DURING TRANSURETHRAL RESECTION OF THE PROSTATE (TURP). BLADDER RECONSTRUCTION WAS SUBSEQUENTLY PERFORMED USING A ROBOT. THE REMAINDER OF THE OPERATION PROCEEDED WITHOUT COMPLICATIONS. THE PROCEDURE WAS COMPLETED. HOWEVER, THERE WAS A DELAY, AND THE SPECIALIST HAD TO PERFORM ADDITIONAL TREATMENT.
Patient problems: Rupture
MAUDE report 25690293 ↗InjuryOct 27, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT, "THE BIPOLAR ELECTRODE WAS CUT IN THE MIDDLE DURING PROCEDURE; SURGEON DIDN'T RECOVER THE BROKEN PIECE. BROKEN PIECE STILL INSIDE THE PATIENT'S BODY." THE MEDICAL PURPOSE OF THE APPLICATION WAS FULFILLED, NO ADDITIONAL UNSCHEDULED MEDICAL ACTIONS NEEDED TO BE TAKEN, BUT THERE WAS A CLINICALLY RELEVANT OPERATING ROOM TIME EXTENSION.
Patient problems: Foreign Body In Patient
MAUDE report 23391906 ↗InjuryMar 25, 2025Material Invagination; Stretched; No Visual Prompts/Feedback; Material Invagination; Stretched; No Visual Prompts/Feedback
IT AS REPORTED THAT DURING BIPOLAR RESECTION OF THE PROSTATE (TUR PROSTATE), THE PATIENT SUDDENLY RECEIVED ELECTRIC SHOCKS WHEN THE CURRENT WAS APPLIED, WHICH CAUSED MUSCLE TWITCHING. AT THE SAME TIME, THERE WERE SCREEN FAILURES. THE RESECTION SNARE WAS REPLACED IMMEDIATELY. DAMAGE TO THE INSULATION OF THE SNARE WAS NOTICED. A SHORT TIME LATER, THE SAME PROBLEM OCCURRED WITH THE FIRST REPLACEMENT SNARE. HERE TOO, THE INSULATION ON THE SLING WAS MISSING. WHEN USING THE 2ND REPLACEMENT SLING, IT WAS OBSERVED THAT THE INSULATION OF THE SLING WAS PULLED INWARDS AS IT WAS EXTENDED AND TIGHTENED UNTIL IT HAD COMPLETELY SLIPPED OUT OF PLACE. THE OPERATION WAS THEN ABORTED. THE USER REPORTED A CLINICALLY RELEVANT INCREASE IN OPERATING TIME OF APPROX. 45 MINUTES. IN ADDITION, THE MEDICAL PURPOSE OF THE APPLICATION COULD NOT BE FULFILLED AS THE PROSTATE COULD NOT BE COMPLETELY RESECTED.
Patient problems: Electric Shock; Twitching
MAUDE report 21687133 ↗InjuryMar 25, 2025Material Invagination; Stretched; No Visual Prompts/Feedback; Material Invagination; Stretched; No Visual Prompts/Feedback
IT AS REPORTED THAT DURING BIPOLAR RESECTION OF THE PROSTATE (TUR PROSTATE), THE PATIENT SUDDENLY RECEIVED ELECTRIC SHOCKS WHEN THE CURRENT WAS APPLIED, WHICH CAUSED MUSCLE TWITCHING. AT THE SAME TIME, THERE WERE SCREEN FAILURES. THE RESECTION SNARE WAS REPLACED IMMEDIATELY. DAMAGE TO THE INSULATION OF THE SNARE WAS NOTICED. A SHORT TIME LATER, THE SAME PROBLEM OCCURRED WITH THE FIRST REPLACEMENT SNARE. HERE TOO, THE INSULATION ON THE SLING WAS MISSING. WHEN USING THE 2ND REPLACEMENT SLING, IT WAS OBSERVED THAT THE INSULATION OF THE SLING WAS PULLED INWARDS AS IT WAS EXTENDED AND TIGHTENED UNTIL IT HAD COMPLETELY SLIPPED OUT OF PLACE. THE OPERATION WAS THEN ABORTED. THE USER REPORTED A CLINICALLY RELEVANT INCREASE IN OPERATING TIME OF APPROX. 45 MINUTES. IN ADDITION, THE MEDICAL PURPOSE OF THE APPLICATION COULD NOT BE FULFILLED AS THE PROSTATE COULD NOT BE COMPLETELY RESECTED.
Patient problems: Electric Shock; Twitching
MAUDE report 21687011 ↗InjuryNov 20, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT "THE RESECTION LOOP BROKE DURING THE OPERATION. A PIECE APPEARS TO HAVE REMAINED IN THE PATIENT'S UTERUS."
Patient problems: Foreign Body In Patient; Insufficient Information
MAUDE report 20738104 ↗MalfunctionOct 3, 2024Melted; Overheating of Device; Melted; Overheating of Device
RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) RECEIVED A MEDSUN REPORT: (B)(4), REGARDING AN ISSUE WITH A CUTTING ELECTRODE BIPO 24FR 12/30°, PART ID: 46221313US, LOT# 51018536. ACCORDING TO THE MEDSUN REPORT, "PROVIDER NOTED ISSUES WITH FOOT PEDAL FOR ERBE NOT CHARGING ELECTRODE, THEN WOULD HEAT SUDDENLY. THE TECH NOTED THAT ELEMENT BURNED "WHITE HOT". WHEN THE LENS CRACKED, SCOPE SET UP WAS REMOVED. THE TECH NEEDED A KELLY CLAMP TO UNSEAT ELECTRODE FROM RESECTOSCOPE. PATIENT EXPERIENCED AGGRESSIVE BILATERAL LEG MOVEMENTS DURING LOOP CAUTERY, REQUIRING MORE SEDATION. TECH NOTED WHAT APPEARED TO BE METAL FLUSH OUT OF PATIENT DURING PROCEDURE AND ASKED PROVIDER; PROVIDER BELIEVED IT MAY HAVE BEEN FROM UROCLIPS THAT WERE BEING REMOVED DURING PROCEDURE. ONCE REMOVED, UROCLIPS APPEARED TO BE COMPLETELY INTACT." ORIGINAL INTENDED PROCEDURE: CYSTOSCOPY WITH TRANSURETHRAL PROSTATECTOMY, CYSTOSCOPY LITHOLAPAXY.
Patient problems: Insufficient Information
MAUDE report 20358712 ↗MalfunctionOct 3, 2024Melted; Overheating of Device; Melted; Overheating of Device
RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) RECEIVED A MEDSUN REPORT: (B)(4), REGARDING AN ISSUE WITH A CUTTING ELECTRODE BIPO 24FR 12/30°, PART ID: 4622.1313, LOT#: 21004634. ACCORDING TO THE MEDSUN REPORT, "PROVIDER NOTED ISSUES WITH FOOT PEDAL FOR ERBE NOT CHARGING ELECTRODE, THEN WOULD HEAT SUDDENLY. LOOP BROKE/MELTED, AND SCOPE SET UP REMOVED. TECH STRUGGLED TO UNSEAT ELECTRODE FROM RESECTOSCOPE. TEAM CHANGED TO 12-DEGREE SCOPE TO COMPLETE CASE." ORIGINAL INTENDED PROCEDURE: CYSTOSCOPY WITH TRANSURETHRAL PROSTATECTOMY.
Patient problems: Insufficient Information
MAUDE report 20358341 ↗MalfunctionOct 1, 2024
THE TIP OF THE BIPOLAR ELECTRODE BROKE OFF OF THE DEVICE WHILE INSIDE THE BLADDER. THE TIP WAS ABLE TO BE RETRIEVED. NO INJURY TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20343222 ↗MalfunctionSep 4, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
RICHARD WOLF GMBH HAS BEEN INFORMED OF AN ISSUE REGARDING A CUTTING ELECTRODE BIPO 22FR 12/30°, PART ID: 8622133, BATCH# 21004873. ACCORDING TO THE RECEIVED INFORMATION, DURING A HYSTEROSCOPY RESECTION, THE ELECTRODE WAS BURNT THROUGH ONE SIDE AT THE END OF THE ARCH. THE HOSPITAL REPORTED THAT THERE WAS NO LOUD SOUND, JUST THE LIGHT WAS BRIGHTER THAN USUAL. THE SURGEON SEARCHED FOR A FRAGMENT OF THE LOOP TIP FOR ABOUT 30 MINUTES JUST IN CASE, BUT NO FRAGMENT WAS FOUND. THE USER REPORTED THE OPERATION WAS COMPLETED WITH A REPLACEMENT AND THERE WAS NO PATIENT INJURY AS A RESULT OF THE INCIDENT.
Patient problems: Insufficient Information
MAUDE report 20138978 ↗MalfunctionApr 10, 2024
AS SOON AS THE CURRENT WAS APPLIED, THE DEVICE POPPED AND BROKE. ONCE THIS HAPPENED, NO LONGER ABLE TO USE THE RESECTOSCOPE AFTER THIS EVENT OCCURRED. THE SCOPE WAS TAKEN OUT OF SERVICE AND SENT TO STERILE PROCESSING DEPARTMENT FOR REPAIRS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19078527 ↗MalfunctionOct 4, 2023Material Fragmentation; Arcing of Electrodes; Material Fragmentation; Arcing of Electrodes
RICHARD WOLF (B)(6) HAS INFORMED RICHARD WOLF GMBH OF AN ISSUE REGARDING A CUTTING ELECTRODE BIPO 22FR 12/30°, PART ID: 8622133, LOT #21004154. ACCORDING TO THE RECEIVED INFORMATION, THE CUTTING ELECTRODE SPARKED AND BROKE DURING A TRANSURETHRAL RESECTION OF BLADDER TUMOR (TURBT) SURGERY. BECAUSE OF THIS, THE CERAMIC TIP (PART ID: 8675322) ON THE INNER SHAFT BROKE. THE BROKEN PART OF THE CERAMIC TIP WAS RETRIEVED. THERE WAS A REPORTED OR TIME EXTENSION OF 15 MINUTES. THE SCHEDULED PROCEDURE WAS COMPLETED.
Patient problems: Insufficient Information
MAUDE report 17869654 ↗MalfunctionJun 20, 2023Material Fragmentation; Excessive Heating; Material Fragmentation; Excessive Heating
A USER FACILITY HAS INFORMED RICHARD WOLF GMBH AN ISSUE REGARDING A CUTTING ELECTRODE BIPO 24FR 12/30°, PART ID: 8622131, LOT # 21003950. ACCORDING TO THE RECEIVED INFORMATION, DURING PROCEDURE THE LOOP HAS BROKEN INSIDE THE BLADDER AND THE LOOP WAS BURNT.
Patient problems: Insufficient Information
MAUDE report 17162657 ↗MalfunctionMay 19, 2023Smoking; Smoking
THE USER FACILITY HAS INFORMED RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) OF AN ISSUE REGARDING A HF BIPOLAR CONNECTING CABLE L 3M, PART ID: 8108.232, BATCH # UNKNOWN. ACCORDING TO THE RECEIVED INFORMATION, THE BIPOLAR CONNECTING CABLE FAILED DURING THE CASE. "DURING PROCEDURE USING THE ERBE MACHINE FOR OPERATIVE PORTION OF PROCEDURE, THE PRINCESS BIPOLAR CORD MADE A LOUD NOISE WHILE INSIDE THE PATIENT. WE SAW THE PORTION OF THE CORD THAT WAS OUTSIDE THE PATIENT WAS SEVERED INTO TWO PIECES.". SMOKE AT THE AREA OF THE BROKEN CORD WAS NOTED BY THE SURGEON. THERE WAS A REPORTED 15 MINUTES DELAY IN THE PROCEDURE. HOWEVER, THE SURGEON MADE THE DECISION TO USE ALTERNATIVE DEVICE TO FINISH CASE. ACCORDING TO THE USER FACILITY, THERE WAS NO INJURY TO THE PATIENT AND THE 15 MINUTES DELAY DID NOT PUT THE PATIENT AT RISK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16966912 ↗MalfunctionMay 19, 2023Smoking; Smoking
THE USER FACILITY HAS INFORMED RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) OF AN ISSUE REGARDING A HF BIPOLAR CONNECTING CABLE L 3M, PART ID: 8108.232, BATCH # UNKNOWN. ACCORDING TO THE RECEIVED INFORMATION, THE BIPOLAR CONNECTING CABLE FAILED DURING THE CASE. "DURING PROCEDURE USING THE ERBE MACHINE FOR OPERATIVE PORTION OF PROCEDURE, THE PRINCESS BIPOLAR CORD MADE A LOUD NOISE WHILE INSIDE THE PATIENT. WE SAW THE PORTION OF THE CORD THAT WAS OUTSIDE THE PATIENT WAS SEVERED INTO TWO PIECES." SMOKE AT THE AREA OF THE BROKEN CORD WAS NOTED BY THE SURGEON. THERE WAS A REPORTED 15 MINUTES DELAY IN THE PROCEDURE. HOWEVER, THE SURGEON MADE THE DECISION TO USE ALTERNATIVE DEVICE TO FINISH CASE. ACCORDING TO THE USER FACILITY, THERE WAS NO INJURY TO THE PATIENT AND THE 15 MINUTES DELAY DID NOT PUT THE PATIENT AT RISK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16966640 ↗MalfunctionNov 9, 2022Mechanical Jam; Mechanical Jam
RICHARD WOLF COMPLAINT REFERENCE NUMBER (B)(4). THE USER REPORTED THE FOLLOWING: DURING A TUR-B, A SHAM DEFECT WAS EVIDENT, THE SLING/SLING SLIT DID NOT SLIDE BACK ON MANUAL COMMAND. A PERFORATION OF THE BLADDER OCCURRED. THIS RESULTED IN A PROLONGATION OF THE OPERATION TIME. THE PROCEDURE COULD BE TERMINATED BY REPLACING THE INSTRUMENTATION. THERE WAS NO PROLONGED HOSPITALIZATION AND THE PATIENT SUFFERED NO PERMANENT DAMAGE. RWGMBH MDR AWARENESS DATE: (B)(6) 2022
Patient problems: No Clinical Signs, Symptoms or Conditions; Perforation
MAUDE report 15760952 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page