EndoRotor® 3.2mm Powered Endoscopic Debridement (PED) Catheter – Gastroscope Oly 3.2-PED-EGD-OPRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00854172008193), received between Dec 1, 2023 and Dec 1, 2023 — 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.

• InjuryDec 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6). 2023 A PANCREATIC NECROSECTOMY WAS PERFORMED ON A PATIENT. THIS WAS THE PATIENT'S 3RD DEBRIDEMENT USING THE ENDOROTOR DEVICE. THE PHYSICIAN STATED THAT ONCE THE THERAPEUTIC SCOPE WAS IN THE NECROTIC CAVITY, THE ENDOROTOR WAS PREPPED. NO OTHER CONVENTIONAL INSTRUMENTS WERE USED PRIOR TO THE USE OF THE ENDOROTOR CATHETER. AFTER ABOUT 15-20 MINUTES OF DEBRIDEMENT USING THE ENDOROTOR CATHETER, THE PHYSICIAN IMMEDIATELY RECOGNIZED SIGNIFICANT BLEED. THE CATHETER WAS QUICKLY REMOVED, AND THE PATIENT'S BLEEDING WAS TENDED TO. THE PATIENT DID NOT REQUIRE TREATMENT TO CONTROL THE BLEEDING AND THE SOURCE OF THE BLEEDING WAS NOT IDENTIFIED. THE BLEEDING CONTINUED FOR ABOUT 40 MINUTES AND THEN SUBSIDED. AFTER THE SCOPE WAS REMOVED, THE PATIENT WAS TRANSPORTED TO THE INTENSIVE CARE UNIT. THE PHYSICIAN STATED THERE WERE NO NOTICEABLE VESSELS AND/OR VISIBLE RISKS DURING THE DEBRIDEMENT. THE PHYSICIAN ADDED THAT THE PATIENT DID NOT HAVE ANY PANCREAS LEFT AND HE AND HIS TEAM WERE AWARE THAT THERE COULD BE VESSELS IN THE NECROTIC CAVITY. THE FOLLOWING MORNING, THE PHYSICIAN FOLLOWED UP AND STATED THAT THE PATIENT WAS STABLE. IT IS SUSPECTED THAT THE BLEEDING STEMMED F

  Patient problems: Pancreatitis

  MAUDE report 18245773 ↗