ReNew 3945Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00811099013808), received between Dec 21, 2023 and Dec 21, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 21, 2023Use of Device Problem; Use of Device Problem

  DURING A GASTRIC BYPASS SLEEVE PROCEDURE, AFTER SURGEON USED THE MICROLINE SUPER ATRAUMATIC FENESTRATED GRASPER, BRUISING WAS NOTED ON THE BOWEL. BEYOND THESE MARKS, THERE WERE NO OTHER ISSUES NOTED AND NO HARM TO INVOLVED PATIENT. OF NOTE, THE SURGEON NOTED THAT THIS SAME SITUATION OCCURRED ON A PRIOR SURGICAL PROCEDURE ON (B)(6) 2023. THIS WAS A NEW PRODUCT BEING USED AT THE ORGANIZATION AFTER HAVING COMPLETED SOME TRIAL CASES WITHOUT INCIDENT. OF NOTE, THE INVOLVED DEVICE, THE RENEWXR HANDLE, IS AN UPDATED MODEL RELEASED BY MICROLINE IN 2023.

  Patient problems: Bruise/Contusion

  MAUDE report 18376142 ↗