ReNew 3904Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00811099010548), received between May 28, 2019 and Apr 7, 2026 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Arcing” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2026Sparking

  DURING THE PROCEDURE, ABOUT 30 MINUTES AFTER START, A SPARK OCCURRED AT THE JOINT BETWEEN THE HANDPIECE AND THE SCISSORS, CAUSING DAMAGE TO TISSUE OUTSIDE THE TREATMENT AREA. THE TISSUE THAT WAS UNINTENTIONALLY DAMAGED WAS A BLOOD VESSEL; HEMOSTASIS WAS ACHIEVED USING AN ALTERNATIVE DEVICE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO SIGNIFICANT PROLONGATION OF THE SURGICAL DURATION OR OTHER ISSUES RELATED TO THE HEMOSTASIS WERE OBSERVED. THE PATIENT IS DOING WELL.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24803151 ↗
• InjuryMay 1, 2025Arcing; Arcing

  PATIENT UNDERWENT A LAPAROSCOPIC OVARIAN CYSTECTOMY. INTRAOPERATIVELY, MONOPOLAR SCISSOR CAUTERIZED AT THE JUNCTION BETWEEN THE SCISSOR TIP AND HANDPIECE HANDLE CAUSING LEFT ILIAC ARTERY BLEED WITH 1000 CC BLOOD LOSS. PATIENT REQUIRED ONE UNIT OF PRBCS TRANSFUSION. VASCULAR SURGERY AND GENERAL SURGERY CONSULTED, AND PATIENT UNDERWENT EMERGENCY LAPAROTOMY WITH LEFT EXTERNAL ILIAC ARTERY REPAIR. UNKNOWN EXTENDED ANESTHESIA TIME. LAPAROSCOPIC OVARIAN CYSTECTOMY PROCEDURE STARTED AT 09:52. INCIDENT OCCURRED AROUND 11:00 AND PATIENT UNDERWENT EMERGENT LAPAROTOMY WITH LEFT EXTERNAL ILIAN ARTERY REPAIR. PROCEDURE ENDED AT 13:22.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Vascular Dissection

  MAUDE report 21945330 ↗
• MalfunctionDec 11, 2024Electrical /Electronic Property Problem; Arcing; Electrical /Electronic Property Problem; Arcing

  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 20907263 ↗
• MalfunctionMay 22, 2024Arcing; Arcing

  PATIENT HAD ARCE INSIDE WHILE PRODUCT (HANDLE & SCISSOR TIP) WERE CONNECTED TO MONOPOLAR. ARCING EVENT OCCURRED. SCISSOR TIP 3142 WAS CONNECTED TO HANDLE 3904.

  Patient problems: Insufficient Information

  MAUDE report 19371532 ↗
• InjuryMar 22, 2024

  LAPAROSCOPIC SHEARS USED DURING SURGERY MALFUNCTIONED AND MELTED THE SHIELDING ON THE SHAFT CAUSING A BURN LESIONS TO THE UTERUS REQUIRING SUTURES AND BURN LESION REMOVAL. THIS IS A REUSABLE INSTRUMENT. HOWEVER, THE TIP OF THE INSTRUMENT IS DISPOSABLE. THE FACILITY DOES REPROCESS THIS DEVICE.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 18969267 ↗
• MalfunctionMar 1, 2023Arcing; Arcing

  HANDLE CREATED AN ELECTRIC ARC INJURING THE PATIENT DURING A VAGINAL OPERATION.

  Patient problems: Burn(s)

  MAUDE report 16461271 ↗
• MalfunctionAug 12, 2019Material Fragmentation; Material Fragmentation

  DURING A PROCEDURE THE O-RING BROKE OFF THE HANDPIECE AND FELL INTO PATIENT ABDOMEN; ALL PIECES WERE RETRIEVED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8883659 ↗
• 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 8741260 ↗
• MalfunctionMay 28, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A PIECE OF THE O-RING BROKE AND FELL INTO THE PATIENT'S ABDOMEN. THE PIECE REMAINED IN THE PATIENT'S BODY. THE PROCEDURE WAS NOT EXTENDED. THE STATUS OF THE PATIENT IS CURRENTLY UNKNOWN.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8646948 ↗