SHARK/S-LINE 46221333Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04055207048870), received between Jun 21, 2017 and Oct 27, 2025 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• InjuryApr 18, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  RICHARD WOLF RECEIVED A MEDWATCH REPORT FROM THE FDA. THE REPORT STATED: "WOLF ELECTRODE USED FOR HYSTEROSCOPY, MYOMECTOMY PRICEDURE: METAL LOOP BROKE OFF DURING PROCEDURE BUT WAS FOUND OUTSIDE OF THE PATIENT, INTACT. " THE ORIGINAL INTENDED PROCEDURE: OPERATIVE HYSTEROSCOPY, MYOMECTOMY, D&C WHAT PROBLEM DID THE USER HAVE: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING). ADDITIONAL INFORMATION RECEIVED THROUGH DIRECT CONTACT WITH THE USER FACILITY: 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? NO. DID THE DELAY PUT THE PATIENT AT RISK? N/A. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? YES. WAS THE SCHEDULED PROCEDURE COMPLETED? YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14137996 ↗
• MalfunctionMar 25, 2022Manufacturing, Packaging or Shipping Problem; No Apparent Adverse Event; Appropriate Device Problem Term/Code Not Available; Manufacturing, Packaging or Shipping Problem; No Apparent Adverse Event; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO RICHARD WOLF (B)(4) BY "THE USER REPORTED THAT THERE WERE DIFFERENT ELECTRODES IN THE PACKAGE (3 PIECES) THAN ACCORDING TO THE LABEL. ACCORDING TO THE LABEL THE ELECTRODE 4622.1333 SHOULD HAVE BEEN IN THE PACKAGE." ADDITIONAL INFORMATION: THE USER FACILITY DISCOVERED PRIOR TO ANY PROCEDURE.. THEY REPORTED NO RISK TO THE PATIENT. ONLY MISLABELING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13903416 ↗
• MalfunctionJan 13, 2022Thermal Decomposition of Device; Thermal Decomposition of Device

  THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF ALL 2016-2017 COMPLAINT FILES THAT RW MIC IS CONDUCTING. THE COMPLAINT SPECIALIST DETERMINED A RE-ASSESSMENT OF THE MDR DECISION FOR THIS COMPLAINT WAS NEEDED AND THAT, THIS COMPLAINT, IF A SIMILAR FAILURE OR MALFUNCTION WERE TO OCCUR WITH THE SAME OR SIMILAR DEVICE, COULD DEATH, LIFE THREATENING INJURY OR LIFE-THREATENING ILLNESS OCCUR, AN MDR SHOULD BE FILED. IT WAS REPORTED TO RICHARD WOLF BY THE USER FACILITY THAT "ELECTRODE STARTED BURNING OUT WITHIN FIRST FEW SECONDS OF BEING ACTIVATED DURING A TRANSURETHRAL RESECTION. TRIED SECOND ELECTRODE WITH THE SAME RESULT. ABLE TO COMPLETE PROCEDURE WITH MONOPOLAR RESECTION SET.." ADDITIONAL DETAILS: WILL THE DEVICE BE RETURNED? YES (RETURNED ON (B)(4)). 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 OTHER PERSONNEL DUE TO ISSUE? NO. DID THE ISSUE CAUSE A DELAY IN THE PROCEDURE BEING PERFORMED THAT PUT THE PATIENT AT RISK? NO. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? YES. WAS THE SCHEDULED PROCEDURE COMPL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13251394 ↗
• MalfunctionJan 12, 2022Thermal Decomposition of Device; Thermal Decomposition of Device

  THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF ALL 2016-2017 COMPLAINT FILES THAT RW MIC IS CONDUCTING. THE COMPLAINT SPECIALIST DETERMINED A RE-ASSESSMENT OF THE MDR DECISION FOR THIS COMPLAINT WAS NEEDED AND THAT, THIS COMPLAINT. IF A SIMILAR FAILURE OR MALFUNCTION WERE TO OCCUR WITH THE SAME OR SIMILAR DEVICE, COULD DEATH, LIFE THREATENING INJURY OR LIFE-THREATENING ILLNESS OCCUR, AN MDR SHOULD BE FILED. IT WAS REPORTED TO RICHARD WOLF BY THE USER FACILITY THAT "ELECTRODE FELL APART DURING SURGERY, LOOP BROKE LOSE ON BOTH SIDES. NO PATIENT INJURY." ADDITIONAL DETAILS: WILL THE DEVICE BE RETURNED? YES (RETURNED ON (B)(4)). 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 OTHER PERSONNEL DUE TO ISSUE? NO. DID THE ISSUE CAUSE A DELAY IN THE PROCEDURE BEING PERFORMED THAT PUT THE PATIENT AT RISK? NO. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? YES. WAS THE SCHEDULED PROCEDURE COMPLETED? YES. HOW WAS THE PATIENT ANESTHETIZED? UNKNOWN. TREND ANALYSIS: 1/11/17: SIMILAR ISSUES, WAITING INVESTIGATION RESULTS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13239669 ↗
• MalfunctionJul 13, 2021Material Fragmentation; Material Fragmentation

  THE PURPOSE OF THIS SUBMISSION IS TO REPORT THE RESULTS OF THE DEVICE INVESTIGATION AND CONTACT WITH THE USER FACILITY. FOR THE DEVICE EVALUATION: THE DEVICE WAS RETURNED TO RICHARD WOLF ON 8/17/2021 AND VISUALLY INSPECTED. FINDINGS: BASE OF LOOP MAY HAVE BEEN BENT AT SOME POINT, WEAKENING THE WIRE AND CAUSING IT TO BURN THROUGH AT BEND AND /OR BREAK OFF WHEN PRESSURE WAS APPLIED DURING THE PROCEDURE. SPECIFIC CAUSE CANNOT BE DETERMINED WITHOUT INFORMATION FROM PROCEDURE (WAS ELECTRODE UNPACKED AND INSTALLED CORRECTLY). WAS VOLTAGE SET TO OPTIMAL LEVEL, ETC.). ROOT CAUSE INDETERMINATE. THE REPORTED CONDITION BY USER FACILITY WAS CONFIRMED. THE DEVICE WAS SCRAPPED. NOTE: ORIGINALLY THE DEVICE WAS NOT GOING TO BE RETURNED, ON 7/27/2021 RW RECEIVED NOTICE THAT THE DEVICE WAS FOUND AND WAS BEING SENT IN FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12158888 ↗
• MalfunctionJul 13, 2021Material Fragmentation; Material Separation; Material Fragmentation; Material Separation

  THE PURPOSE OF THIS SUBMISSION IS TO REPORT THE RESULTS OF THE PRODUCT HISTORY INVESTIGATION BY RW GMBH. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE PRODUCT HISTORY EVALUATION STATES "IN THE PAST THREE YEARS (>01/01/2018), RICHARD WOLF GMBH HAS RECEIVED FIVE COMPLAINTS INCLUDING THE CURRENT COMPLAINT (B)(4) REGARDING THE 46221333 CUTTING ELECTRIC EDGE BIPO 22CH 12/20 WITH VARIOUS DAMAGES AND CAUSES OUTSIDE THE USA. HOWEVER, THERE HAVE BEEN NO COMPLAINTS SIMILAR TO THOSE DESCRIBED ABOVE. EXCESSIVE FORCE APPLIED BY THE USER MAY RESULT IN MECHANICAL FAILURE OF THE WIRE HANDLE. THE USER IS THEREFORE ADVISED IN THE INSTRUCTIONS FOR USE TO KEEP THE FORCE APPLICATION LOW. POSSIBLE HAZARDS ARE CONSIDERED IN THE RISK ASSESSMENT BB2-3 REB. 05 WITH THE CORRESPONDING EXTENT OF DAMAGE AND PROBABILITY OF OCCURRENCE ARE ASSESSED WITH AN ACCEPTABLE RISK. THIS ASSESSMENT IS STILL VALID EVEN TAKING IN ACCOUNT THE CURRENT CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12158538 ↗
• MalfunctionJun 18, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  SEE MANUFACTURERS NARRATIVE FOR RESULTS OF THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12025193 ↗
• MalfunctionJun 21, 2017Break; Break

  FACILITY REPORT TO RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) THAT DURING A PROCEDURE THE CUTTING LOOP BROKE OFF AND FELL INTO BLADDER. FOREIGN OBJECT WAS ABLE TO BE RETRIEVED. NO INJURY TO PATIENT OR STAFF REPORTED.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 6658086 ↗