ReNew 3152Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00811099010012), received between Jan 7, 2020 and Jul 16, 2025 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2025Sparking; Sparking

  MICROLINE WAS MADE AWARE OF WHAT APPEARED TO BE AN ELECTRICAL SAFETY FAILURE EVENT OF A MICROLINE LAPARSCOPIC HANDPIECE AND A MICROLINE SCISSOR TIP DURING USE OF MONOPOLAR CAUTERIZATION DURING A PROCEDURE. THE PROCEDURE REPORTED WAS A HYSTERECTOMY AND BILATERAL SALPINGECTOMY. PATIENT WAS NOT HARMED, AND THE STAFF HAD NOTICED WHAT APPEARED TO BE MELTING AND CHARGING OF THE DISTAL SHAFT AND SCISSOR TIP OF THE MICROLINE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22520807 ↗
• MalfunctionDec 26, 2024Fracture; Fracture

  THE HEAT SHRINK FELL INTO THE ABDOMINAL CAVITY AND WAS RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21018736 ↗
• 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 TOTAL 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. THIS REPORT IS FOR THE TIP THAT WAS ATTACHED TO THE HANDPIECE AT THE TIME OF THE INCIDENT.

  Patient problems: Bowel Burn

  MAUDE report 20644137 ↗
• MalfunctionOct 23, 2024Fracture; Fracture

  THE HEAT SHRINK FELL INTO THE ABDOMINAL CAVITY DURING AN OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20514188 ↗
• MalfunctionMar 7, 2024Fracture; Fracture

  DURING THE SURGERY, THE HEAT SHRINK OF THE TIP CAME OFF. WE CONFIRMED THE HEAT SHRINK WAS COMPLETELY OFF AND THE METAL PARTS WERE PARTIALLY EXPOSED. WE ASSUME THE HEAT SHRINK CAME OFF DUE TO THE CONTACT OF THE COMBINATION INSTRUMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18857214 ↗
• MalfunctionFeb 23, 2023Fracture; Fracture

  A CAPA (170) WAS OPENED TO IDENTIFY THE ROOT CAUSE AND PROVIDE A CORRECTIVE ACTION. THE PRELIMINARY RESULT OF THIS INVESTIGATION INDICATE THAT THERE WAS AN ISSUE RELATED TO TEMPERATURE AND THE DWELL TIME IN THE OVEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16430054 ↗
• MalfunctionJan 10, 2023Loss of or Failure to Bond; Break; Loss of or Failure to Bond; Break

  DURING THE SURGERY, HEAT SHRINK CAME OFF AND FELL INTO THE ABDOMINAL CAVITY. IT WAS REMOVED FROM THE ABDOMINAL CAVITY AND THERE WAS NO HEALTH PROBLEM FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16133936 ↗
• MalfunctionDec 15, 2022Material Fragmentation; Material Fragmentation

  DURING THE SURGERY, HEAT SHRINK CAME OFF AND FELL INTO THE ABDOMINAL CAVITY. IT WAS REMOVED FROM THE ABDOMINAL CAVITY AND THERE WAS NO HEALTH PROBLEM FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15991792 ↗
• MalfunctionAug 24, 2022Defective Component; Defective Component

  TUBING CASING BROKE OFF IN PATIENT COMPLAINT: SCISSOR TIP WAS SCREWED ONTO HANDLE 0 ISSUES NOTED. SURGEON USED SCISSORS INSIDE PT. - PULLED OUT SCISSORS AND SAID "OH ITS GRABBING WHEN I PULLED IT OUT" I INSPECTED THE TIP - NOTED 'SOMETHING WAS DIFFERENT' BUT DIDN'T REALIZE THE TUBING CASING WAS OFF UNTIL SURGEON LOOKED IN ABDOMEN & FOUND THE PIECE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15283243 ↗
• MalfunctionSep 28, 2021Device Handling Problem; Device Handling Problem

  DURING A PROCEDURE, OUR CUSTOMER FOUND THAT THE PART WHICH SHOULD BE ADHERED CAME OFF. THE SURGEON IMMEDIATELY PICKED IT UP THUS THERE WAS NEITHER HEALTH DAMAGE NOR EXTENSION OF THE PROCEDURE. A SPARE INSTRUMENT WAS USED TO CONTINUE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12542613 ↗
• MalfunctionJan 7, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  A THIRD OF THE PROTECTIVE SHEATH CAME OFF THE END OF THE SCISSOR TIP.

  Patient problems: No Information

  MAUDE report 9560100 ↗