ENDOPATH BASX TB12LTRecalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10705036003007), received between Oct 24, 2017 and Jan 15, 2025 — classified as 2 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Crack” (15 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 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• InjuryJan 15, 2025Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHEN THE TROCARS WERE REMOVED, IT WAS DISCOVERED THAT A PIECE HAD BROKEN OFF THE INNER EDGE OF ONE TROCAR. THE BROKEN PIECES WERE THEN SEARCHED FOR IN THE ABDOMEN. AFTER A LENGTHY SEARCH, TWO SMALL PIECES WERE FOUND AND REMOVED. THE OPERATING TIME WAS GREATLY EXTENDED AND A SMALL PIECE OF THE TROCAR COULD NOT BE FOUND.

  Patient problems: Foreign Body In Patient

  MAUDE report 21164181 ↗
• MalfunctionJun 20, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, IT WAS 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 19574790 ↗
• MalfunctionMar 7, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE DEVICE WAS RECEIVED WITH NO EVENT DETAILS. ATTEMPTS WERE MADE TO OBTAIN DETAILS AND NO INFORMATION WAS PROVIDED. NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18857222 ↗
• MalfunctionJan 17, 2024Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, IT WAS 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 18528219 ↗
• MalfunctionAug 18, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, WHEN OPENING THE PACKAGING IT WAS 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 17573581 ↗
• MalfunctionJun 29, 2023Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHEN THE TROCAR WAS REMOVED, IT WAS FOUND THAT A SMALL PIECE AT THE FRONT END OF THE TROCAR WAS DAMAGED. THE DAMAGED PART WAS STILL CONNECTED WITH THE TROCAR AND WAS NOT LEFT IN THE PATIENT'S BODY. CHANGED TO A NEW DEVICE TO COMPLETE SURGERY. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17229082 ↗
• MalfunctionJun 14, 2023Crack; Crack

  IT WAS REPORTED THAT DURING AN ENDOSCOPIC STOMACH SURGERY, AFTER INSERT INTO THE TROCAR, NOTED ONE DEVICE WAS BROKEN ,AND ANOTHER DEVICE HAD CRACKS . ANOTHER TWO DEVICE WERE 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 17130118 ↗
• MalfunctionJun 14, 2023Crack; Crack

  IT WAS REPORTED THAT DURING AN ENDOSCOPIC STOMACH SURGERY, AFTER INSERT INTO THE TROCAR, NOTED ONE DEVICE WAS BROKEN ,AND ANOTHER DEVICE HAD CRACKS . ANOTHER TWO DEVICE WERE 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 17130091 ↗
• MalfunctionMay 24, 2023Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TIP OF TROCAR WAS NOTED BROKEN WHILE THE NURSE WAS CHECKING THE OPERATION ITEMS. AFTER CONFIRMING NO PIECES IN PATIENT, THE SURGEON COMPLETED THE SURGERY. HOWEVER, THE SURGERY WAS EXTENDED FOR ABOUT 2 HOURS DUE TO LOOKING FOR THE BROKEN PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16992935 ↗
• MalfunctionApr 5, 2023Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TIP OF TROCAR RUPTURED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16681044 ↗
• MalfunctionApr 5, 2023Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TIP OF TROCAR RUPTURED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16681028 ↗
• MalfunctionApr 5, 2023Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TIP OF TROCAR RUPTURED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16681021 ↗
• MalfunctionApr 5, 2023Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TIP OF TROCAR RUPTURED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16681010 ↗
• MalfunctionApr 5, 2023Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TIP OF TROCAR RUPTURED DURING 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 16680883 ↗
• MalfunctionApr 5, 2023Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TIP OF TROCAR RUPTURED DURING 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 16680840 ↗
• MalfunctionApr 5, 2023Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TIP OF TROCAR RUPTURED DURING 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 16680826 ↗
• MalfunctionJan 18, 2023Component or Accessory Incompatibility; Material Integrity Problem; Component or Accessory Incompatibility; Material Integrity Problem

  IT WAS REPORTED THAT DURING A GASTRIC BYPASS, THE TROCAR SEAL WAS LEAKING. THE LEAKAGE IS CAUSED BY THE SEAL BEING DAMAGED FROM THE ENDO-GIA STAPLER BEING REMOVED THROUGH THE TROCAR. PROCEDURE PROLONGED 5 MINUTES. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16194485 ↗
• MalfunctionJan 18, 2023Component or Accessory Incompatibility; Material Integrity Problem; Component or Accessory Incompatibility; Material Integrity Problem

  IT WAS REPORTED THAT DURING A GASTRIC BYPASS, THE TROCAR SEAL WAS LEAKING. THE LEAKAGE IS CAUSED BY THE SEAL BEING DAMAGED FROM THE ENDO-GIA STAPLER BEING REMOVED THROUGH THE TROCAR. PROCEDURE PROLONGED 5 MINUTES. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16194446 ↗
• MalfunctionJan 18, 2023Component or Accessory Incompatibility; Material Integrity Problem; Component or Accessory Incompatibility; Material Integrity Problem

  IT WAS REPORTED THAT DURING A GASTRIC BYPASS, THE TROCAR SEAL WAS LEAKING. THE LEAKAGE IS CAUSED BY THE SEAL BEING DAMAGED FROM THE ENDO-GIA STAPLER BEING REMOVED THROUGH THE TROCAR. PROCEDURE PROLONGED 5 MINUTES. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16194397 ↗
• MalfunctionJan 18, 2023Component or Accessory Incompatibility; Material Integrity Problem; Component or Accessory Incompatibility; Material Integrity Problem

  IT WAS REPORTED THAT DURING A GASTRIC BYPASS, THE TROCAR SEAL WAS LEAKING. THE LEAKAGE IS CAUSED BY THE SEAL BEING DAMAGED FROM THE ENDO-GIA STAPLER BEING REMOVED THROUGH THE TROCAR. PROCEDURE PROLONGED 5 MINUTES. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16194311 ↗
• MalfunctionJan 18, 2023Component or Accessory Incompatibility; Material Integrity Problem; Component or Accessory Incompatibility; Material Integrity Problem

  IT WAS REPORTED THAT DURING A GASTRIC BYPASS, THE TROCAR SEAL WAS LEAKING. THE LEAKAGE IS CAUSED BY THE SEAL BEING DAMAGED FROM THE ENDO-GIA STAPLER BEING REMOVED THROUGH THE TROCAR. PROCEDURE PROLONGED 5 MINUTES. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16194288 ↗
• MalfunctionApr 14, 2022Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, AFTER INSERTING THE TROCAR, NOTED THE TROCAR WAS DAMAGED AS 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 14113195 ↗
• MalfunctionApr 14, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, BEFORE USED ON THE PATIENT, 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 14113026 ↗
• MalfunctionApr 14, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, BEFORE USED ON THE PATIENT, 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 14112960 ↗
• MalfunctionJan 28, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE SURGERY FOR TREATMENT OF ADENOCARCINOMA OF COLON, "WHEN THE DEVICE WAS PLACED INTO THE ABDOMINAL CAVITY WITH FORCEPS FOR THE PATIENT, THE SEALING OF THE DEVICE FELL INTO THE ABDOMINAL CAVITY IMMEDIATELY." THE DOCTOR IMMEDIATELY SUSPENDED THE SURGERY, FIRST REMOVED THE SEALING, WHICH DELAYED THE PROGRESS OF THE SURGERY, THEN CHANGED TO ANOTHER DEVICE TO COMPLETE THE SURGERY. PATIENT CONSEQUENCE WAS NOT REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13385393 ↗