ReNew 3925Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00811099010616), received between Dec 28, 2018 and Oct 5, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Arcing” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 5, 2021Smoking; Smoking

  REUSABLE LAPAROSCOPIC INSTRUMENTS AND DISPOSABLE TIP WERE INSPECTED PRIOR TO PUTTING TOGETHER FOR ANY VISUAL DEFECTS. NONE NOTED. WHILE SURGEON WAS USING A EXTRALONG MICROLINE LAPAROSCOPIC HANDLED INSTRUMENT WITH A DISPOSABLE SCISSOR TIP, SURGICAL FIRST ASSISTANT NOTICE A PLUME COMING FROM THE THREADED PORTION, THE DISTAL END OF INSTRUMENT. SURGEON WAS ASKED TO STOP AND IT WAS OBSERVED THAT THERE WAS 1/3 OF CM THERMAL DAMAGE. GENERAL SURGEON WAS CONSULTED AND OVERSEWED THE INJURY. THE INJURY DID NOT ENTER THE SEROSAL LAYER AND THE GENERAL SURGEON DID STATE THAT IT COULD HAVE BEEN LEFT ALONE BUT SINCE HE WAS THERE IT WAS OVERSEWN. THE AREA OF INJURY WAS THE DESCENDING COLON.

  Patient problems: Bowel Burn

  MAUDE report 12578150 ↗
• InjuryDec 28, 2018Arcing; Arcing

  THERE WAS A BURNING LESION TO THE STOMACH AS A RESULT OF A DEFECT IN THE INSULATION FROM THE SHAFT OF THE LAPAROSCOPIC INSTRUMENT. ANESTHESIA TIME WAS EXTENDED FOR 15 MINUTES. NO FOLLOW-UP MEDICAL TREATMENT WAS REQUIRED.

  Patient problems: Burning Sensation

  MAUDE report 8202329 ↗