SHARK/S-LINE 8622131Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04055207018019), received between Sep 18, 2018 and Jun 20, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionSep 23, 2022Material Fragmentation; Melted; Material Fragmentation; Melted

  RICHARD WOLF GMBH COMPLAINT REFERENCE NUMBER (B)(4). THE USER HAS REPORTED THE FOLLOWING: A TUR BLADDER RESECTION WAS PLANNED. THE LOOP MELTED IMMEDIATELY WHEN THE RESECTION PEDAL WAS PRESSED. THE REST OF THE LOOP (PART OF THE ARCH) WAS REMOVED, THE REST WERE TINY BALLS WHICH WERE EVACUATED WITH THE HELP OF A BUBBLE SYRINGE. THE APPLICATION WAS COMPLETED WITH A REPLACEMENT ELECTRODE. SURGERY TIME INCREASED BY 25 MINUTES. RWGMBH AWARENESS DATE, (B)(6) 2022.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15470477 ↗
• MalfunctionSep 21, 2022Material Disintegration; Overheating of Device; Material Disintegration; Overheating of Device

  RICHARD WOLF GMBH COMPLAINT REFERENCE NUMBER: (B)(4) (FU1 MDR / DEVICE EVALUATION). THE PURPOSE OF THIS SUBMISSION IS TO REPORT THE RESULTS OF THE DEVICE EVALUATION. DEVICE EVALUATION: RWGMBH AWARENESS DATE, 09-JAN-2023.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15461800 ↗
• MalfunctionMay 3, 2022Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED TO RWMIC BY THE MANUFACTURER THAT "ON APRIL 12, 2022 RICHARD WOLF (B)(4) WAS INFORMED ABOUT THE FOLLOWING: AT THE TIME OF A RESECTION OF A BLADDER POLYP, THE DISTAL TIP OF THE CUTTING ELECTRODE MELTED LEAVING ROUND PARTI-CLES SIMILAR TO SMALL METAL BALLS IN THE BLADDER. THE SURGEON THEN ATTEMPTED TO REMOVE THESE SMALL BALLS, WHICH RESULTED IN A DELAY OF 30 MINUTES. THE TREATMENT COULD BE COMPLETED. THIS CASE WAS REPORTED BY THE CUSTOMER TO (B)(6)."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14269005 ↗
• MalfunctionNov 10, 2020Break; Break

  THE FOLLOWING WAS REPORTED TO RW (B)(4): ON (B)(6) 2020 AT 12:14:59, UNDER COMBINED SPINAL AND EPIDURAL ANESTHESIA, THE OPERATION WAS STOPPED IMMEDIATELY DUE TO THE RUPTURE OF THE ELECTROSURGICAL RING. THIS INCIDENT DID NO CAUSE AN IMPACT ON THE PATIENTS. SOPPED USING. NO EFFECT ON PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10816682 ↗
• MalfunctionSep 18, 2018Improper or Incorrect Procedure or Method

  RICHARD WOLF (B)(4), HEREINAFTER REFERRED TO AS (B)(4) WAS NOTIFIED OF AN EVENT THAT OCCURRED AT THE USER FACILITY ON AN UNSPECIFIED DATE. IT WAS REPORTED THAT THE SURGICAL TEAM AT THE HOSPITAL USED (B)(4) CUTTING ELECTRODE (B)(4) (BLISTER PACKAGING) IN OPERATIONS WITHOUT PRIOR TREATMENT. THE HOSPITAL CONSIDERED THE CUTTING ELECTRODE TO BE STERILE. THE CUTTING ELECTRODE WAS DISCARDED BY THE CUSTOMER. THERE WAS NO REPORT OF ADVERSE OUTCOME TO THE PATIENT AS A CONSEQUENCE OF THIS EVENT. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7885655 ↗