ENDOPATH BASX CTB12LTRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10705036001515), received between Oct 24, 2017 and Jan 18, 2023 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• 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 16194547 ↗
• 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 16194539 ↗
• 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 16194491 ↗
• 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 16194476 ↗
• 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 16194305 ↗
• MalfunctionDec 15, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AND UNKNOWN PROCEDURE, THE TROCAR MEMBRANE RELEASED, AND FELL INTO THE ABDOMINAL CAVITY. THERE WAS NO DELAY TO PROCEDURE, AND MEMBRANE WAS REMOVED FROM THE ABDOMINAL CAVITY. SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11013739 ↗
• MalfunctionMay 31, 2019Failure to Form Staple; Device Fell

  IT WAS REPORTED THAT AFTER A LAPAROSCOPIC GASTRIC SLEEVE, WHERE A BASX TROCAR WAS USED. THE TROCAR REDUCER WAS INSIDE THE PATIENT. INTERVENTION WAS REQUIRED DUE TO THE SITUATION. THE SURGEON IDENTIFIED THE STAPLE LINE WAS BLEEDING SO HE NEEDED TO OPERATE THAT PATIENT AGAIN. THE INCISION WAS NOT MADE BIGGER. THE INTRA-OP PROCEDURE WAS NOT CHANGED BECAUSE THE SURGEON DID NOT REALIZE THE REDUCER CUP FELL INTO THE PATIENT DURING THE PROCEDURE. NO XRAYS WERE TAKEN TO ASSIST IN LOCATING THE REDUCER CAP. THE SURGEON REALIZED THAT REDUCER CUP WAS INSIDE THE PATIENT ONCE HE WAS OPERATING THE PATIENT AGAIN. THE PATIENT IS SAFE AND AT HOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8659892 ↗
• MalfunctionMay 31, 2018Break

  ACCORDING TO SURGEON THE TIP OF THE SLEEVE BREAKS WITH VERY LITTLE MOVEMENT OF THE INSTRUMENTS OR WHILE INSERTING IN THE ABDOMINAL WALL WITH OPTURATOR. HIS CONCERN IS ABOUT THE QUALITY OF THE PRODUCT AND PATIENT SAFETY. PROCEDURE: UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7556458 ↗
• MalfunctionMay 31, 2018Break

  ACCORDING TO SURGEON THE TIP OF THE SLEEVE BREAKS WITH VERY LITTLE MOVEMENT OF THE INSTRUMENTS OR WHILE INSERTING IN THE ABDOMINAL WALL WITH OPTURATOR. HIS CONCERN IS ABOUT THE QUALITY OF THE PRODUCT AND PATIENT SAFETY. PROCEDURE: UNKNOWN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7556439 ↗
• MalfunctionMay 31, 2018Break

  ACCORDING TO SURGEON THE TIP OF THE SLEEVE BREAKS WITH VERY LITTLE MOVEMENT OF THE INSTRUMENTS OR WHILE INSERTING IN THE ABDOMINAL WALL WITH OPTURATOR. HIS CONCERN IS ABOUT THE QUALITY OF THE PRODUCT AND PATIENT SAFETY. PROCEDURE: UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7556358 ↗
• InjuryMay 31, 2018Break; Component Falling

  ACCORDING TO SURGEON THE TIP OF THE SLEEVE BREAKS WITH VERY LITTLE MOVEMENT OF THE INSTRUMENTS OR WHILE INSERTING IN THE ABDOMINAL WALL WITH OPTURATOR. SURGEON FILLS THAT THE PART OF THE BROKEN SLEEVE MAY PRESENT IN THE ABDOMINAL WALL AS FOR FOREIGN PARTICLE. ALSO, SURGEON COMPLAINT THAT THE BROKEN PART OF THE SLEEVE BREAKS AND FALLED IN THE CAVITY IF THE STOMACH. HIS CONCERN IS ABOUT THE QUALITY OF THE PRODUCT AND PATIENT SAFETY. PROCEDURE: UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 7556276 ↗
• MalfunctionOct 24, 2017Break

  IT WAS REPORTED THAT PRIOR TO AN ENDOSCOPIC RIGHT COLECTOMY, BEFORE USE ON THE PATIENT, THE PACKAGING WAS 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 6973156 ↗