ENDOPATH BASX TB5LTRecalls & reported problems
Ethicon Endo-Surgery, LLC · Endopath BASX Bladeless Trocars with Stability Sleeves · Class 2
Quick summary
This Ethicon Endopath BASX trocar is a bladeless tube used to create access for laparoscopic surgery. Reports mostly describe damaged sterile packaging found before use and trocar tips or housings cracking or breaking, with another device used to finish the procedure. There are 24 reports naming its identifier, with no deaths and no injuries, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 24
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10705036003021), received between Sep 13, 2018 and Apr 6, 2026 — classified as 24 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (8 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.
Reports received per month
Most reported problems
Device problems
- Delivered as Unsterile Product8
- Crack7
- Tear, Rip or Hole in Device Packaging6
- Break4
- Manufacturing, Packaging or Shipping Problem2
- Material Integrity Problem2
- Packaging Problem1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions15
- No Consequences Or Impact To Patient10
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 6, 2026Delivered as Unsterile Product
IT WAS REPORTED THAT DURING THE UNK SURGERY, BEFORE USED ON THE PATIENT, NOTED THE PACKING WAS DAMAGED(AS THE PHOTO SHOWS. 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 24793225 ↗MalfunctionApr 3, 2026Delivered as Unsterile Product
IT WAS REPORTED THAT DURING AN UNK PROCEDURE, BEFORE USED ON THE PATIENT, OPENED THE PACKING, FOUND THE SEAL FILM DAMAGED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24779622 ↗MalfunctionApr 3, 2026Material Integrity Problem
IT WAS REPORTED THAT DURING AN UNK PROCEDURE, BREATHER VALVE FELL OFF WAS FOUND DURING THE SURGERY. 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 24779570 ↗MalfunctionJul 12, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT BEFORE THE SURGERY, IT WAS NOTED THAT THE 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 Clinical Signs, Symptoms or Conditions
MAUDE report 17305267 ↗MalfunctionApr 7, 2023Crack; Crack
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TIP OF THE TROCAR WAS BROKEN. PUNCH IS EVIDENT. NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16700755 ↗MalfunctionDec 7, 2022Crack; Crack
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TIP OF THE TROCAR WAS BROKEN. NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15931906 ↗MalfunctionApr 11, 2022Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE AND DURING THE TROCAR ENTRY THE LOW-HOUSING PROFILE PART OF TROCAR WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14078978 ↗MalfunctionDec 17, 2021Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, BEFORE USED ON THE PATIENT, NOTED THE PACKING 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 13030036 ↗MalfunctionNov 3, 2021Crack; Crack
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, BEFORE USED ON THE PATIENT, NOTED THE DEVICE WAS BROKEN (SLEEVE ISSUE). ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12749958 ↗MalfunctionJul 13, 2021Crack; Manufacturing, Packaging or Shipping Problem; Crack; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, BEFORE USED ON THE PATIENT, IT WAS NOTED THAT THE DEVICE WAS BROKEN. THERE WAS A CRACK. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12164269 ↗MalfunctionJul 9, 2021Crack; Manufacturing, Packaging or Shipping Problem; Crack; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, BEFORE USED ON THE PATIENT, NOTED THE DEVICE WAS BROKEN. THERE IS A CRACK. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12146216 ↗MalfunctionJul 9, 2021Delivered as Unsterile Product; Delivered as Unsterile Product
DAMAGED PACKAGING. IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, BEFORE USED ON THE PATIENT, NOTED THE PACKAGE WAS BROKEN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12145745 ↗MalfunctionJun 15, 2021Crack; Crack
IT WAS REPORTED THAT DURING LAPAROSCOPIC HEPATECTOMY SURGERY , NOTED THE DEVICE WAS DAMAGED (TROCAR CANULA WAS BROKEN). 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 11996981 ↗MalfunctionMay 12, 2021Crack; Use of Device Problem; Crack; Use of Device Problem
IT WAS REPORTED THAT DURING COLON RESECTION/LAR THERE WAS RUPTURE OF THE CANNULA OF A BASIX TROCAR DURING THE FINAL PHASE OF THE LAR LAPAROSCOPIC PROCEDURE. BREAKAGE PROBABLY DUE TO A MANEUVER OF OVERLOADING THE WEIGHT EXERTED AGAINST THE RIBS. THERE WAS NO DELAY TO PROCEDURE, NO FRAGMENTS WERE GENERATED, SURGERY WAS SUCCESSFULLY COMPLETED, AND THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11813926 ↗MalfunctionAug 12, 2020Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, BEFORE USED ON THE PATIENT, NOTED THE PACKING 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 10395485 ↗MalfunctionJul 9, 2020Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT DURING THE SURGERY, BEFORE USED ON THE PATIENT, NOTED THE PACKING WAS DAMAGED (THE EDGE WAS NOT SEALED PROPERLY). 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; No Consequences Or Impact To Patient
MAUDE report 10255366 ↗MalfunctionJul 7, 2020Delivered as Unsterile Product; Delivered as Unsterile Product
DAMAGED PACKAGING. IT WAS REPORTED THAT DURING AN UNKNOWN STOMACH SURGERY, BEFORE USED ON THE PATIENT, NOTED THE PACKING WAS DAMAGED(AS THE PHOTO SHOWS.) 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 10242198 ↗MalfunctionApr 10, 2019Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE PACKING WAS DAMAGED WHEN THE RECEIVED AT THE DISTRIBUTOR. NOT INVOLVED IN ANY SURGERY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8499682 ↗MalfunctionApr 10, 2019Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE PACKING WAS DAMAGED WHEN THE RECEIVED AT THE DISTRIBUTOR. NOT INVOLVED IN ANY SURGERY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8499663 ↗MalfunctionSep 13, 2018Break; Tear, Rip or Hole in Device Packaging
PACKAGING BREAKAGE. FOUND THE STERILE PACKAGING WAS DAMAGED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7874033 ↗MalfunctionSep 13, 2018Tear, Rip or Hole in Device Packaging
PACKAGING BREAKAGE. FOUND THE STERILE PACKAGING WAS DAMAGED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7874002 ↗MalfunctionSep 13, 2018Break; Tear, Rip or Hole in Device Packaging
PACKAGING BREAKAGE. FOUND THE STERILE PACKAGING WAS DAMAGED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7873985 ↗MalfunctionSep 13, 2018Break; Tear, Rip or Hole in Device Packaging
PACKAGING BREAKAGE. FOUND THE STERILE PACKAGING WAS DAMAGED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7873956 ↗MalfunctionSep 13, 2018Break; Packaging Problem
PACKAGING BREAKAGE. FOUND THE STERILE PACKAGING WAS DAMAGED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7873950 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.