EndoRotor® 6.0mm Endoscopic Powered Resection (EPR) Catheter 6.0-EPR-EGDRecalls & reported problems
Interscope, Inc · EndoRotor® 6.0mm Endoscopic Powered Resection (EPR) Catheter · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00854172008117), 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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Perforation1
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
THE TREATING PHYSICIAN REQUESTED ENDOROTOR CATHETERS TO ASSIST IN THE TREATMENT OF A SCARRED GASTRIC LESION MEASURING APPROXIMATELY 4CM X 3CM AT THE AXIAL/LONGITUDINAL AXIS RESPECTIVELY. A PREVIOUS PROCEDURE WAS ATTEMPTED TO RESECT THE LESION, BUT THE GI PHYSICIAN COULD NOT ACCESS THE LESION DUE TO ANATOMICAL POSITIONING OF THE LESION. THE GI PHYSICIAN THEN COORDINATED WITH A BARIATRIC SURGEON TO PERFORM A HYBRID PROCEDURE LATER. THE HYBRID PROCEDURE HAD TWO OBJECTIVES: PROVIDE TRACTION TO THE GASTRIC WALL TO FACILITATE POSITIONING FOR THE ENDOSCOPIC TREATMENT. IN THE EVENT THE ENDOROTOR PROCEDURE WAS UNSUCCESSFUL THE SURGEON WAS AVAILABLE AND READY TO SURGICALLY RESECT THE SITE. THE PATIENT WAS PREPPED AND DRAPED IN ACCORDANCE WITH GENERAL SURGERY. THREE PORTS WERE CREATED INTO THE PATIENT'S PERITONEAL CAVITY INCLUDING TWO INSTRUMENT PORTS AND CAMERA PORT. USING STANDARD LAPAROSCOPIC TECHNIQUE, INSUFFLATING THE SURGICAL SITE THE SURGEON DISSECTED CONNECTIVE TISSUES UNTIL THE INFERIOR/ANTERIOR GASTRIC WALL WAS EXPOSED. THE SURGEON THEN PROVIDED TRACTION TO THE GASTRIC WALL FROM THE PERITONEAL SPACE ALLOWING THE GI PHYSICIAN TO ACCESS THE SITE. THE PHYSICIAN TREATED THE AREA USING T
Patient problems: Perforation
MAUDE report 13804535 ↗
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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