ENDOPATH DEXTRUSRecalls & reported problems across all models

We found 3 models of ENDOPATH DEXTRUS by Ethicon Endo-Surgery, LLC in the FDA's device registry (GUDID). Together they are named in 27 adverse event reports in the FDA's MAUDE database, received between Nov 30, 2017 and Nov 15, 2024 — classified as 1 injury, 26 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (11 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported ENDOPATH DEXTRUS problems

ENDOPATH DEXTRUS models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ENDOPATH DEXTRUS FLR01

  Laparoscope, general & plastic surgery
  11 reports
• ENDOPATH DEXTRUS HAP02

  Laparoscope, general & plastic surgery
  11 reports
• ENDOPATH DEXTRUS FLR02

  Laparoscope, general & plastic surgery
  5 reports

Recent ENDOPATH DEXTRUS adverse event reports

The 15 most recent reports across all models, 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, DEVICE BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19314485 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗

Other Ethicon Endo-Surgery, LLC products

• Harmonic ACE9 models · 12,862 reports
• ECHELON FLEX7 models · 9,393 reports · 1 recall
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• ENDOPATH37 models · 2,785 reports
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