ReNew 3262Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00811099010081), received between Oct 9, 2019 and Aug 27, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2024Material Fragmentation; Material Fragmentation

  THE PATIENT CAME TO OR FOR THE PROCEDURE OF LAP/OPEN APPENDECTOMY. DURING THE SURGERY, THE INSULATION FROM THE TIP OF THE GRASPER DETACHED AND PART OF IT WAS FOUND INSIDE THE ABDOMEN. THE PIECE WAS REMOVED AND IT WAS CONFIRMED THAT THERE WERE NO MORE PIECES INSIDE THE ABDOMEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20076318 ↗
• MalfunctionAug 14, 2024Material Fragmentation; Material Fragmentation

  SHRINK WRAP FELL OFF THE TIP 3262, LONG FENESTRATED. THE SHRINK WRAP CAME OFF WHILE THE HANDLE WAS BEING PULLED OUT OF THE TROCAR. SHRINK WRAP WAS FOUND INSIDE THE TROCAR. NO INJURY WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19984505 ↗
• MalfunctionOct 9, 2019Material Fragmentation; Material Fragmentation

  ON (B)(6) 2019, DURING A LAPAROSCOPIC SIGMOID COLECTOMY, THE HEAT SHRINK ON A 3262 LONG FENESTRATED DISPOSABLE GRASPER CAME OFF DURING THE PROCEDURE AND HAD TO BE RETRIEVE FROM THE PATIENT'S ABDOMEN BY SURGEON.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9171871 ↗