ReNew 3941Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00811099013761), received between May 20, 2024 and Feb 19, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Arcing” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2025Sparking; Sparking

  DURING A THL PROCEDURE DR. SANTAMARIA FLORES AND OR STAFF NOTICED THAT THE MICROLINE HANDPIECE AND SCISSOR TIP BEGAN SPARKING AT THE END OF THE CASE DURING MONOPOLAR CAUTERIZATION. SETTINGS WERE REPORTED AS "35 CUT BLEND, COAG 35." THE INSTRUMENT WAS REMOVED FROM THE PATIENT, AND THE DISTAL END APPEARED MELTED AND CHARRED. THE INSTRUMENT WAS PUT ASIDE, AND THE MANUFACTURER WAS CONTACTED. NO BURNS OR INJURY TO PATIENT WERE REPORTED AT TIME OF FILING THIS AIR REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21413264 ↗
• InjuryJan 17, 2025Electrical /Electronic Property Problem; Arcing; Electrical /Electronic Property Problem; Arcing

  WHILE OPERATING IN THE ABDOMINAL CAVITY A BURN ON OVARIAN TISSUE WAS NOTICED BY SURGEONS. THEY STATED THEY HAD THE DISP. SCISSOR TIP ON THE MICROLINE PISTOL HANDLE IN VIEW AT ALL TIMES AND DIDN'T SEE IT TOUCH THE TISSUE THAT APPEAR TO HAVE THE SCORCH MARK ON IT. INSTRUMENT WAS MARKED AND LABELED AS BROKEN; PLACED BACK IN THE TRAY FOR PROCESSING. PROCESSING CENTER INDICATES THAT THIS WAS PROCESSED PER PROCEDURE AND PASSED ALL QUALITY TEST OF LAPAROSCOPIC EQUIPMENT.

  Patient problems: Burn(s)

  MAUDE report 21179271 ↗
• InjuryNov 8, 2024Electrical /Electronic Property Problem; Arcing; Electrical /Electronic Property Problem; Arcing

  DURING THE PROCEDURE, THE ASSISTING SURGEON DISCOVERED A MONOPOLAR BURN TO THE BOWEL OF THE PATIENT. THE SURGEONS THEN BACKTRACKED THROUGH THE PROCEDURE TO CHECK FOR OTHER NON-NOTICED BURNS TO THE PATIENT. SURGEONS REPORTED FINDING 3 ADDITIONAL MONO POLAR BURNS TO THE PATIENT BOWEL, FOR A TOAL OF 4 BURNS. SURGEONS DID NOT NOTICE THE BURNS UPON IMMEDIATE USE OF MONOPOLAR ELECTRO SURGICAL CAUTERY. NO VISUALIZATION OF ELECTRICAL ARCING WAS REPORTED AT THE TIME OF INCIDENT BY THE SURGEONS OR STAFF, HOWEVER THE DISTAL PORTION OF THE RENEW XR HANDPIECE DEMONSTRATES PHYSICAL DAMAGE. SOURCE OF MONOPOLAR ENERGY WAS RECORDED TO BE A VALLEY LAB FT10 SERIAL NUMBER (B)(6). SETTINGS USED WERE CUT 35 COAG BLEND, 35 COAG.

  Patient problems: Bowel Burn

  MAUDE report 20643496 ↗
• MalfunctionMay 20, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  (B)(6) HOSPITAL IN (B)(6) , RI EXPERIENCED AN ELETRCIAL ARCING INCIDENT WHILE USING THE MONOPOLAR FUNCTION OF A MICROLINE XR HANDPIECE, AND A MICROLINE SCISSOR TIP. THE HANDPIECE, AND SCISSOR TIP HAVE BEEN RETRIEVED AND SENT BACK TO MICROLINE SURGICAL HEADQUARTERS FOR FURTHER INVESTIGATION. MONOPOLAR SETTINGS USED INSIDE OF THE PATIENT WERE 60/40, AND THEN 35/45. STAFF ATTHE FACILITY STATED THAT THE PATIENT WASN'T HARMED, HOWEVER THE INSTRUMENT DID ARC WHILE INSIDE THE PATIENT CAVITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19353023 ↗