EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter – Colonoscope Long 3.2-EPR-COL-OPRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00854172008131), received between Mar 18, 2022 and Mar 18, 2022 — classified as 1 injury.

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 18, 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.

• InjuryMar 18, 2022Adverse Event Without Identified Device or Use Problem

  TARGET AREA FOR ER RESECTION: TRANSVERSE COLON, 2CM X 0.5CM SCARRED TISSUE BED TOTAL TIME FOR EMERGENCY ROOM RESECTION: 15MIN. ORIENTATION OF SCAR BED TO SCOPE: LENGTH OF SCAR BED WAS EAST TO WEST (3 > 9 O'CLOCK ON A FACE OF A CLOCK) PHYSICIAN NOTED A 'HOLE' IN THE COLON TISSUE. UPON GOING BACK TO 9 O'CLOCK SECTION TO CONTINUE RESECTING, IT WAS NOTED THERE WAS A 'HOLE' AT 7-8 O'CLOCK. EMERGENCY ROOM CATHETER WAS IMMEDIATELY REMOVED FROM SCOPE AND 10 CLIPS WERE USED TO CLOSE THE 5-6MM PERFORATION SITE 10 CLIPS WERE USED TO CLOSE THE PERFORATION. PT WAS STABLE. THE ANTIBIOTICS AND CT HAD BEEN ORDERED AND PATIENT WAS TO BE ADMITTED FOR OBSERVATION.

  Patient problems: Perforation

  MAUDE report 13804529 ↗