SHARK/S-LINE 8108232Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04055207000908), received between Sep 29, 2020 and May 19, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Smoking” (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.

• 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 ↗
• MalfunctionApr 1, 2022Material Separation; Sparking; Material Separation; Sparking

  RW MIC RECEIVED A MEDWATCH REPORT FROM THE FDA ON MARCH 3, 2022. IT WAS REPORTED THAT "DURING TRANSURETHRAL RESECTION OF PROSTATE, R. WOLF BIPOLAR CORD (8108232) SPARKED/EXPLODED OFF INSTRUMENT WHILE IN USE (BIPOLAR TURP SETTING PRESET). FDA SAFETY REPORT ID# (B)(4)."

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

  MAUDE report 13978380 ↗
• MalfunctionSep 29, 2020Sparking; Sparking

  USER FACILITY RETURNED THE DEVICE TO RWMIC ON OCTOBER 6, 2020, AND THE EVALUATION WAS COMPLETED ON OCTOBER 22, 2020: THE REPORTED CONDITION WAS VERIFIED USING VISUAL AND MECHANICAL TESTING. IT WAS DETERMINED THAT THE CABLE SEEMS TO BE WORN FROM WEAR AND TEAR, STRAINS APPEAR TO BE BROKEN DUE TO FATIGUE CAUSING SPARK. THE ROOT CAUSE WAS DETERMINED TO BE NORMAL WEAR AND TEAR. THE DEVICE DOES NOT MEET THE SPECIFICATIONS THEREFORE PRODUCT DISPOSITION IS DETERMINED TO BE SCRAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10599616 ↗