ENDOPATH XCEL B5STRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10705036001232), received between Feb 14, 2018 and May 7, 2026 — classified as 1 injury, 21 malfunctions.

The most frequently reported specific device problem is “Crack” (7 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THERE SEEMS TO HAVE BLACK STAIN IN THE PACKAGE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25114187 ↗
• MalfunctionJan 16, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING THE UNK SURGERY, 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 24099520 ↗
• MalfunctionDec 26, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE UNK SURGERY, THE SURGEON NOTED THE DEVICE HAD AIR LEAKAGE ISSUE. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. 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 23899349 ↗
• MalfunctionDec 15, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING THE UNK SURGERY, 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 23804532 ↗
• MalfunctionSep 15, 2025Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE TROCAR WAS BENDING WHILE IT WAS INSERTED INTO THE BODY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23052548 ↗
• MalfunctionDec 31, 2024Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, TROCAR WAS BENT DURING THE PROCESS OF INSERTION. REPLACED WITH NEW DEVICE. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21047960 ↗
• MalfunctionDec 11, 2024Component or Accessory Incompatibility; Component or Accessory Incompatibility

  IT WAS REPORTED THAT DURING OB-GYN PROCEDURE, ENSEAL HAS BEEN ENCLOSED WITH THE TROCAR. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20905929 ↗
• MalfunctionApr 17, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE PARTS INSIDE THE SHEATH HAD FALLEN OFF BEFORE USING. CHANGED TO A NEW DEVICE TO COMPLETE SURGERY. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19126055 ↗
• MalfunctionFeb 22, 2024Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, NOTED THE DEVICE 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 18764043 ↗
• MalfunctionJan 12, 2024Crack; Crack

  IT WAS REPORTED THAT DURING A HEPATECTOMY PROCEDURE, THE TROCAR WAS BENT. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18502494 ↗
• MalfunctionDec 28, 2023Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, A FOREIGN MATTER LIKE A BUG WAS INSIDE BEFORE THE PACKAGE WAS OPENED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18409825 ↗
• MalfunctionJul 27, 2023Crack; Crack

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC OB-GYN PROCEDURE, THE INNER CYLINDER WAS BENT WHEN THE TROCAR WAS PUNCTURED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17405887 ↗
• MalfunctionApr 18, 2023Crack; Crack

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRECTOMY, THERE WAS A CRACK ON THE TIP. WHEN THE TROCAR WAS PUNCTURED, THE CRACK GOT WORSE. THE DEVICE WAS USED ON THE STOMACH. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ONE DEVICE WILL BE RETURNING. HOWEVER, THE DEVICE HAS BEEN WASHED BEFORE RETURNING, AND THE CRACK GOT WORSE THAN IT WAS, SO THE CONDITION OF THE DEVICE IS NOT SAME AS WHEN THE ISSUE WAS FOUND AT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16760919 ↗
• MalfunctionFeb 14, 2023Crack; Component or Accessory Incompatibility; Crack; Component or Accessory Incompatibility

  IT WAS REPORTED THAT DURING A DIGESTIVE SURGERY, THE SURGEON FELT THAT THE FORCEPS WAS CAUGHT WHEN INSERTING THROUGH THE TROCAR. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16373541 ↗
• MalfunctionMar 31, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, AN UNEXPECTED SOUND WAS HEARD WHEN A FORCEPS WAS INSERTED/REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13966958 ↗
• MalfunctionFeb 18, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE RUBBER OF THE TROCAR FELL INTO THE BODY. IT WAS TAKEN OUT FROM THE PATIENT AND WAS DISCARDED. PATIENT CONSEQUENCE WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13564244 ↗
• InjuryFeb 11, 2022Use of Device Problem; Material Integrity Problem; Use of Device Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRECTOMY, A "RUBBERY THING" FELL INTO THE ABDOMINAL CAVITY. THERE IS A POSSIBILITY THAT IT WAS FROM A COMPETITIVE DEVICE. THE DEVICE WAS USED ON THE STOMACH. THE SURGEON COMMENTED THAT A FORCEPS OR AN ELECTRIC DEVICE CLAMPED THE DEVICE. THE PROCEDURE WAS NOT CONVERTED TO AN OPEN PROCEDURE WHEN THE FALLEN PART WAS RETRIEVED. IT IS UNKNOWN WHETHER ALL PIECES WERE PICKED UP. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCE TO THE PATIENT. THE PATIENT¿S CONDITION IS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 13518338 ↗
• MalfunctionJan 24, 2022Material Integrity Problem; Noise, Audible; Material Integrity Problem; Noise, Audible

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC OOPHORECTOMY, AN UNEXPECTED SOUND WAS HEARD DURING USE. WHEN THE INSIDE OF THE HOUSING WAS CHECKED, IT WAS FOUND THAT THE VALVE WAS NOT CLOSED AT ALL. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13339383 ↗
• MalfunctionAug 19, 2020Particulates; Particulates

  SEE USER FACILITY MEDWATCH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10425630 ↗
• MalfunctionJan 15, 2020Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE BROKE. THE BROKEN PIECES WERE RETRIEVED, BUT THE CUSTOMER REQUESTED THE INVESTIGATION TO REVEAL ALL THE BROKEN PIECES WERE RETRIEVED JUST IN CASE SOME PIECES FELL INSIDE THE PATIENT. SMALL BLACK PIECES ARE RUBBER GASKET FROM INSIDE THE TROCAR SLEEVE AND ARE NOT HARD PLASTIC FROM OUTSIDE OF THE DEVICE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9594075 ↗
• MalfunctionOct 19, 2018Difficult to Insert; Material Deformation

  IT WAS REPORTED THAT UPON OPENING THE TROCAR FROM PACKAGING, THEY NOTICED A SMALL DENT IN THE SLEEVE OF TROCAR THAT MADE IT VERY DIFFICULT TO INSERT AND REMOVE THE OBTURATOR FROM THIS SLEEVE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7985399 ↗
• MalfunctionFeb 14, 2018Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC MYOMECTOMY, THE TIP OF THE OUTER SLEEVE WAS BEND AFTER A MYOMA BORER WAS INSERTED. THEN, THE TIP OF THE OUTER SLEEVE WAS BROKEN OFF WHEN THE DEVICE WAS REMOVED FROM THE PATIENT. THE DEVICE WAS USED ON THE UTERUS. NO PIECES WERE LEFT INSIDE THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7270437 ↗