SHARK/S-LINE 46241313Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04055207048924), received between Jul 3, 2019 and Aug 19, 2022 — classified as 1 injury, 3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 19, 2022Break; Break

  ON JULY 20, 2022 RICHARD WOLF GMBH WAS INFORMED BY RW UK ABOUT AN ADVERSE EVENT. RICHARD WOLF GMBH COMPLAINT REFERENCE: (B)(4). PATIENT A WAS ATTENDING UROLOGY THEATRE FOR THE FOLLOWING PROCEDURE: CYSTOSCOPY, BLADDER BIOPSIES, RE-DO GREEN LIGHT LASER PROSTATECTOMY (GLLP) AND TRANS-URETHRAL RESECTION OF PROSTATE (TURP). WHILST USING THE WOLF BIPOLAR HANDPIECE WITH CUTTING ELECTRODE ATTACHMENT (LOOP) FOR THE TURP, THE METAL WIRE OF THE LOOP BROKE AWAY AT ONE SIDE. THIS LOOP WAS IMMEDIATELY REMOVED BY SURGEON A WHO REQUESTED ANOTHER WHICH NURSE A PROVIDED TO REPLACE THE DAMAGED ELECTRODE. HOWEVER, THIS LOOP THEN BROKE AWAY ENTIRELY FROM THE TIP INTO THE BLADDER WHEN SURGEON A RESUMED THE PROCEDURE. THE PROCEDURE THEN HAD TO BE COMPLETED USING MONOPOLAR DIATHERMY. RWGMBH AWARENESS DATE, 20-JULY-2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15260992 ↗
• MalfunctionJul 22, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  RICHARD WOLF GMBH COMPLAINT REFERENCE (B)(4). RICHARD WOLF IN (B)(4) (MANUFACTURER) WAS INFORMED ABOUT THE USER MESSAGE TO THE ITALIAN COMPETENT AUTHORITY VIA DISTRIBUTOR. DURING THE RESECTION OF THE PROSTATE, THE BREAK OF TWO TIP OF THE LOOP WAS DETECTED IN TWO ELECTRODES. THE FIRST ONE WAS EXTRACTED BROKEN BUT STILL WHOLE OUT FROM THE BLADDER. THE SECOND ONE WAS EXTRACTED COMPLETELY BROKEN WITHOUT THE DISTAL LOOP OF THE BIPOLAR ELECTRODE. THE SURGEON PROCEEDED WITH A CYSTOSCOPY NOT DETECTING ANY FRAGMENTS INSIDE THE BLADDER ASSUMING THAT THE SAME HAD COME OUT DURING THE EXTRACTION OF THE INSTRUMENT. THIS CASE WAS REPORTED BY THE USER TO THE ITALIAN AUTHORITIES. THE PRODUCTS WERE EXCHANGED AND THE TREATMENT COULD BE COMPLETED WITHOUT ANY SIGNIFICANT DELAY. THERE WERE NO CONSEQUENCES FOR THE PATIENT. RWGMBH AWARENESS DATE, 01-JULY-2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15084926 ↗
• MalfunctionFeb 3, 2020Break; Break

  ON JANUARY 3RD, 2020, RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC) RECEIVED VOLUNTARY EVENT REPORT # MW5091826.. THE FOLLOWING WAS REPORTED: LOOP ELECTRODE USED FOR "TURP" PROCEDURE BROKE OFF DURING USE. SURGEON RETRIEVED BROKEN LOOP AND REMOVED IT FROM THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient

  MAUDE report 9660228 ↗
• InjuryJul 3, 2019Material Integrity Problem; Material Integrity Problem

  ON JUNE 10TH, 2019, RWMIC WAS NOTIFIED THAT REPORT MW5087014 WAS SUBMITTED TO FDA FROM THE USER FACILITY. USER FACILITY REPORTED THE FOLLOWING: DURING CYSTOSCOPY, TRANSURETHRAL RESECTION OF PROSTATE WITH BIPOLAR LOOP, THE LOOP (TIP) OF THE 26FR BIPOLAR ELECTRODE BROKE OFF INSIDE THE PATIENT. SURGEON UNABLE TO VISUALIZE THE BROKEN PIECE INSIDE THE PATIENT USING THE CYSTOSCOPE. REMOVED REMAINDER OF ELECTRODE FROM STERILE FIELD, PLACED IN BIOHAZARD BAG WITH PACKAGE. X-RAY TAKEN NEGATIVE FOR FOREIGN BODY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8759049 ↗