Resectr™ M0065907051Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729964537), received between Aug 7, 2019 and Mar 10, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON FEBRUARY 28, 2019 THAT A RESECTOR 5 FR WAS USED IN A POLYPECTOMY PROCEDURE IN THE UTERUS PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, UPON STARTING TO SHAVE THE POLYP THE INTERNAL RESECTING BLADE BROKE OFF AND FELL INSIDE THE PATIENT. REPORTEDLY, IT WAS SUCCESSFULLY RETRIEVED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WAS NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9811008 ↗
• InjuryAug 7, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JULY 16,2019 THAT A RESECTR RESECTING DEVICE WAS USED DURING A POLYPECTOMY PROCEDURE IN THE COLON WAS PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BLADE OF THE RESECTING DEVICE DETACHED INSIDE THE PATIENT WHILE CUTTING AND WAS REMOVED USING GRASPERS. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESECTING DEVICE. THERE WERE NO SERIOUS INJURIES TO THE PATIENT AND THE PATIEN WAS REPORTED TO BE FINE AFTER THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8870594 ↗