ENDOPATH DEXTRUS FLR01Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705036001966), received between Nov 30, 2017 and May 14, 2024 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, DEVICE BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19314485 ↗
• MalfunctionFeb 14, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A HAND ASSISTED LAPAROSCOPIC PARTIAL COLECTOMY, THE CLEAR RETRACTION PORTION WAS COMING OFF OF THE RING. A NEW DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16371791 ↗
• MalfunctionMay 24, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE PLASTIC SEPARATED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14488163 ↗
• MalfunctionOct 6, 2021Manufacturing, Packaging or Shipping Problem; Material Split, Cut or Torn; Manufacturing, Packaging or Shipping Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING HALS RECTAL SURGERY, OPENED THE PACKING, NOTED THE DEVICE 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12587014 ↗
• MalfunctionAug 26, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A GASTRIC CANCER SURGERY, AFTER FIRED, NOTED THAT THE DEVICE WAS BROKEN INTO A FEW PIECES. ALL PARTS WERE TAKEN OUT FROM THE PATIENT. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12375730 ↗
• MalfunctionAug 11, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING RECTAL CANCER SURGERY, AFTER FIRED, NOTED THAT THE DEVICE WAS BROKE INTO A FEW PIECES. ALL PARTS WERE TAKEN OUT FROM THE PATIENT. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12306668 ↗
• MalfunctionAug 19, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A BOWEL PROCEDURE, THE RETRACTOR DEVICE FELL APART WHEN IN USE BY THE SURGEON, WHICH WAS INCONVENIENT FOR THE SURGEON AND OR STAFF. THERE WERE NO PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10428259 ↗
• MalfunctionJun 18, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC RADICAL RESECTION OF RECTAL CANCER, OPENED THE PACKING AND NOTED THE DEVICE WAS DAMAGED AND SEPARATED. 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 10171912 ↗
• MalfunctionMar 1, 2018Break

  DEVICE BREAKAGE. OPENED THE PACKING, FOUND THE DEVICE WAS BROKEN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7306641 ↗
• MalfunctionNov 30, 2017Unsealed Device Packaging

  SEAL BROKEN. OPENED THE PACKING, BEFORE USED ON PATIENT, FOUND THE SEAL BROKEN. ANOTHER LIKE PRODUCT WAS USED TO COMPLETE THE PROCEDURE. THERE IS NO REPORT ON THE PATIENT'S INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7072669 ↗
• MalfunctionNov 30, 2017Unsealed Device Packaging

  SEAL BROKEN. OPENED THE PACKING, BEFORE USED ON PATIENT, FOUND THE SEAL BROKEN. ANOTHER LIKE PRODUCT WAS USED TO COMPLETE THE PROCEDURE. THERE IS NO REPORT ON THE PATIENT'S INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7072640 ↗