ENDOPATH DEXTRUS FLR02Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705036001973), received between Jun 11, 2018 and May 31, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 31, 2023Manufacturing, Packaging or Shipping Problem; Material Split, Cut or Torn; Manufacturing, Packaging or Shipping Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE BROKE IMMEDIATELY AFTER OPENING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17032261 ↗
• MalfunctionMay 31, 2023Manufacturing, Packaging or Shipping Problem; Material Split, Cut or Torn; Manufacturing, Packaging or Shipping Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE BROKE IMMEDIATELY AFTER OPENING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17032189 ↗
• MalfunctionJul 6, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING THE ENDOSCOPIC HAND-ASSISTED GASTRIC CANCER, BEFORE USED ON THE PATIENT, PACKAGING WAS NOT OPENED HOWEVER IT WAS NOTED THAT THE INNER PACKAGING (STERILE PACKAGING) WAS DAMAGED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10237586 ↗
• MalfunctionSep 10, 2019Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHILE THE SURGEONS HAND WAS IN THE DEVICE AND IN THE PATIENT, THERE WAS A ¿POP¿ AND A PIECE OF THE PLASTIC HAD BROKEN OFF AND HAD TO BE RETRIEVED FROM INSIDE THE PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8984767 ↗
• MalfunctionJun 11, 2018Torn Material

  PULLED IT LIGHTLY, BUT TEAR. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7586198 ↗