ReNew 3142Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00811099010005), received between Jul 17, 2018 and Nov 6, 2025 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Arcing” (2 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Nov 1, 2017Terminated

   Certain lots of disposable laparoscopic instrument tips may potentially have a compromised sterile barrier.

   Z-1741-2018 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 6, 2025Fracture; Fracture

  COMPONENT BROKE DURING USE.

  Patient problems: Insufficient Information

  MAUDE report 23487803 ↗
• MalfunctionAug 1, 2025Use of Device Problem; Device Fell; Use of Device Problem; Device Fell

  A WHITE SILICONE BAND WAS INADVERTENTLY LEFT ON THE DEVICE TIP AND SUBSEQUENTLY DISLODGED INTO THE PATIENT'S CHEST CAVITY DURING THE INITIAL PROCEDURE ON (B)(6) 2025. THE SURGEON CLOSED THE CHEST WITHOUT NOTICING THE BAND. DURING A SUBSEQUENT REOPERATION FOR AN UNRELATED REASON ON (B)(6) 2025, THE SILICONE BAND WAS DISCOVERED AND REMOVED. THE SILICON BAND WAS REMOVED SAFELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22690324 ↗
• MalfunctionMar 20, 2025Failure to Cut; Failure to Cut

  DURING A LAPAROSCOPIC OVARIAN CYSTECTOMY, THE DEVICE FAILED TO OPEN AND CLOSE DURING A CRITICAL PART OF THE PROCEDURE. THE TIP WAS REMOVED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21653178 ↗
• MalfunctionDec 11, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  PATIENT WAS TAKEN BACK FOR A DIAGNOSTIC LAPAROSCOPIC PROCEDURE FOR ENDOMETRIOSIS LESIONS. TWO LESIONS WERE REMOVED WITH THE MONOPOLAR SCISSORS AND LAPAROSCOPIC GRASPER. THE LESION WAS REMOVED AND UPON MOVING FURTHER AWAY FROM THE SITE WITH THE CAMERA, IT WAS IDENTIFIED THAT THE MONOPOLAR SCISSOR HAD BURNED THE FUNDAL SEROSA OF THE UTERUS IN 2 LOCATIONS AS WELL AS THE LEFT FALLOPIAN TUBE SUPERFICIALLY. THIS WAS DONE AT THE CONNECTION OF THE MONOPOLAR SCISSORS TO THE LAPAROSCOPIC INSTRUMENT AND A FAULT IN THE INSULATION OF THIS CONNECTION. THE SCISSOR TIPS AND THE LAPAROSCOPIC INSTRUMENT WERE IMMEDIATELY SWITCHED OUT FOR A NEW SET AND WERE WORKING APPROPRIATELY.

  Patient problems: Burn(s)

  MAUDE report 20907063 ↗
• MalfunctionJun 27, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE NURSE REALIZED THAT THE EDGE OF THE BACK HUB WAS DENTED. IT SEEMS THAT THIS PART WAS INITIALLY DENTED SINCE THE HANDPIECE WASINTACT AND THE EDGE OF THE DENT PART WAS SMOOTH. WE CANNOT DENY THE POSSIBILITY OF THE IMPACT ON INSULATION PROPERTIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19624683 ↗
• InjuryApr 11, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING A LAP REMOVAL OF ADNEXAL/OVARY, A NON-MEDTRONIC DEVICE WAS BEING USED WITH THE GENERATOR AND CORD. AT THE POINT WHERE THE MICROLINE DISPOSABLE ATTACHED TO THE INSTRUMENT MELTED WHICH CAUSED A BURN AND PERFORATION OF THE UTERUS. WHEN INSTRUMENT WAS REMOVED EVERYTHING APPEARED TO BE CONNECTED PROPERLY. THE PERFORATION WAS SUTURED AND ADDITIONAL HOSPITAL STAY WAS NOT REQUIRED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

  Patient problems: Internal Organ Perforation; Superficial (First Degree) Burn

  MAUDE report 19087564 ↗
• MalfunctionJul 8, 2022Defective Component; Defective Component

  NAME PLATE COLLAR SPLIT IN HALF INTRAOPERATIVELY UNABLE TO FIND ONE HALF OF THE PIECE. THE DISLODGED (PLASTIC PORTION) PORTION OF THE TIP WAS NEVER RECOVERED AFTER THE PROCEDURE. SALES REP INDICATES THAT THE TIP SPLIT LONGITUDINALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14958471 ↗
• MalfunctionSep 3, 2021Fracture; Fracture

  DURING A LAP CHOLE THE BLACK PLASTIC (HEAT SHRINK) ON A DISPOSABLE SCISSOR TIP CAME APART AND HAD TO BE RETRIEVED FROM THE PATIENT'S ABDOMEN. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12420575 ↗
• MalfunctionJun 27, 2019Arcing; Arcing

  MALE PATIENT IN THE OR FOR A LAPAROSCOPIC RIGHT INGUINAL HERNIA REPAIR. DURING THE PROCEDURE, THE SURGEON FIRED THE HANDPIECE OF THE LAPAROSCOPIC SCISSORS PRIOR TO USING THEM ON THE PATIENT. WHEN HE DID THAT, THE HANDPIECE ARCED AND CAUSED A SPARK AND SMOKE TO COME FROM THE TIP OF THE HANDPIECE, WHICH BURNED THROUGH THE RUBBER INSULATION ON THE SIDE. THE INSTRUMENT WAS IMMEDIATELY REMOVED AND A NEW SCISSOR TIPS AND HANDLE WERE OBTAINED. THE PROCEDURE CONTINUED AS PLANNED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8741259 ↗
• InjuryJul 17, 2018Arcing; Arcing

  DURING THE RELEASE OF THE GALLBLADDER WITH THE LAPAROSCOPIC SCISSORS, A SPARK APPEARED AT THE DISPOSABLE TIP, WHICH BURNED THE DUODENUM. THE PROCEDURE AND ANESTHESIA TIME WERE EXTENDED FOR AN UNKNOWN AMOUNT OF TIME.

  Patient problems: Burn(s)

  MAUDE report 7695753 ↗