ENDOPATH DEXTRUS HAP02Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705036002055), received between Feb 23, 2018 and Nov 15, 2024 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 15, 2024

  SURGEON ASKED FOR WOUND PROTECTOR (DEXTRUS SEAL CAP ASSEMBLY). ITEM WAS LOCATED AND OPENED AND FOUND TO BE BROKEN. AN ADDITIONAL WOUND PROTECTOR WAS IN THE ROOM AND OPENED AS A REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20694399 ↗
• MalfunctionMay 14, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19313859 ↗
• InjuryAug 30, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A COLORECTAL BOWEL PROCEDURE, THE DEXTRUS CAP BROKE DURING PROCEDURE. PROCEDURE WAS SWITCHED TO OPEN PROCEDURE BECAUSE FACILITY HAD NO PRODUCT AVAILABLE. UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17653504 ↗
• MalfunctionOct 25, 2019Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, HAP02 TIP HAS TORN OFF. IT IS UNKNOWN HOW PROCEDURE WAS COMPLETED. PATIENT CONSEQUENCE WAS NOT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9242323 ↗
• MalfunctionFeb 14, 2019Material Puncture/Hole

  OPENED A DEXRUS SEAL CAP ASSEMBLY TO USE DURING SURGERY AND THE DEVICE HAD A HOLE IN IT . HAD TO GET A NEW ONE. KEPT DEVICE AND TURNED IT IN TO MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8343253 ↗
• MalfunctionOct 18, 2018Break

  DEVICE BREAKAGE. OPENED THE PACKING, NOTED THE SEAL WAS DAMAGED. 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 7978042 ↗
• MalfunctionJun 28, 2018Hole In Material; Gas/Air Leak

  IT WAS REPORTED THAT DURING A LOWER ANTERIOR BOWEL RESECTION, WHILE THE SURGEON WAS USING DEVICE, HE NOTICED GAS LEAKING AND REALIZED THERE WAS A SMALL HOLE IN THE DEVICE. THERE WERE NO PATIENT CONSEQUENCES, PROCEDURE WAS COMPLETED OPEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7647604 ↗
• MalfunctionJun 11, 2018Torn Material

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7586191 ↗
• MalfunctionMar 5, 2018Unsealed Device Packaging

  DEVICE BREAKAGE. DURING THE UNKNOWN SURGERY, BEFORE USED ON THE PATIENT, OPENED THE PACKING, FOUND THE SEAL WAS BROKEN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. OUR CUSTOMER SUSPECT IF THE SEAL WAS STICKY TO THE PLASTIC PACKING RESULTS THE SEAL BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7313809 ↗
• MalfunctionMar 5, 2018Break; Device Damaged Prior to Use; Device Packaging Compromised

  DEVICE BREAKAGE. DURING THE UNKNOWN SURGERY, BEFORE USED ON THE PATIENT, OPENED THE PACKING, FOUND THE SEAL WAS BROKEN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. OUR CUSTOMER SUSPECT IF THE SEAL WAS STICKY TO THE PLASTIC PACKING RESULTS THE SEAL BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7313795 ↗
• MalfunctionFeb 23, 2018Break

  DEVICE BREAKAGE. DURING THE UNKNOWN SURGERY, BEFORE USED ON THE PATIENT, OPENED THE PACKING, FOUND THE SEAL WAS BROKEN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. OUR CUSTOMER SUSPECT IF THE SEAL WAS STICKY TO THE PLASTIC PACKING RESULTS THE SEAL BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7292601 ↗