SHARK/S-LINE 46221313Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04055207048856), received between Mar 10, 2017 and Jul 2, 2026 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 9 most recent of 9 reports, 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionAug 8, 2022Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  RICHARD WOLF GMBH COMPLAINT REFERENCE (B)(4). RICHARD WOLF IN KNITTLINGEN (MANUFACTURER) WAS INFORMED ABOUT THE USER REPORT TO THE SPANISH COMPETENT AUTHORITY VIA DISTRIBUTOR. DESCRIPTION OF INCIDENT/CLAIM: THE DISTAL PART OF THE CUTTING ELECTRODE LOOSENS SPONTANEOUSLY AT THE BEGINNING OF THE SURGERY. THE USER THEN SEARCHED FOR THE BROKEN ELECTRODE FRAGMENT WITH A CYSTOSCOPE. THE FRAGMENT WAS RECOVERED AND THE TREATMENT WAS COMPLETED WITH A NEW ELECTRODE. CONSEQUENCES FOR THE PATIENT WERE DESCRIBED AS A PROLONGED OPERATING TIME. NO INFORMATION WAS GIVEN ON THE DURATION OF THE DELAY. THIS CASE WAS REPORTED BY THE USER TO THE (B)(6) AUTHORITIES. RWGMBH AWARENESS DATE, (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15184497 ↗
• MalfunctionOct 11, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PURPOSE OF THIS SUBMISSION IS TO REPORT THE INFORMATION RECEIVED FROM THE USER FACILITY. THE ORIGINAL PROCEDURE ((B)(6) 2021), DURING WHICH THE WIRE LOOP WAS LOST, WAS A CYSTO LASER LITHALOPAXY. DESCRIPTION OF THE EVENT OR PROBLEM: "RESECTOSCOPE LOOP WAS USED DURING PROCEDURE. PATIENT RETURNED FOR SURGERY ON (B)(6) 2021. AFTER INSERTION OF SCOPE, LOOP PIECE THAT HAD PREVIOUSLY BEEN USED WAS FOUND.". THE USER FACILITY RECONFIRMED THAT THE DEVICES USED DURING THE 9/14/2021 PROCEDURE ARE NOT AVAILABLE FOR INVESTIGATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 12609238 ↗
• MalfunctionSep 20, 2019Break; Break

  ON AUGUST 22, 2019, RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) RECEIVED VOLUNTARY EVENT REPORT (MW5088816). IT WAS REPORTED THAT AN ELECTROCAUTERY LOOP BROKE DURING A PROCEDURE. THE HOSPITAL STAFF WAS UNABLE TO DETERMINE IF ALL THE PIECES WERE STILL PRESENT. THE SURGEON DID A VISUAL INSPECTION TO EXAMINE THE ENTRY AND TO LOCATE ANY MISSING PIECES. NONE WERE FOUND OR VISUALIZED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9100884 ↗
• MalfunctionMar 10, 2017Break; Device Issue; Break; Device Issue

  RICHARD WOLF INSTRUMENT CORPORATION (RWMIC) HAS RECEIVED A MEDWATCH REPORT (REPORT # (B)(4) ), ON (B)(6) 2017. FACILITY HAS REPORTED AN EVENT WHERE THE LOOP BROKE OFF INTO PATIENT DURING A HYSTEROSCOPY PROCEDURE. THERE WAS A DELAY IN THE PROCEDURE IN ORDER TO RETRIEVE FOREIGN OBJECT FROM PATIENT THAT MAY HAVE PUT THE PATIENT AT RISK. BACK UP DEVICE WAS USED TO COMPLETE THE PROCEDURE, AFTER FOREIGN OBJECT HAD BEEN REMOVED. NO INJURY TO PATIENT HAS BEEN REPORTED.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6396549 ↗