ENDOPATH XCEL B12SRTRecalls & reported problems

Summary

The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 10705036001188), received between Dec 5, 2017 and Sep 24, 2026 — classified as 2 injuries, 66 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (37 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 68 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Material Integrity Problem

  It was reported that, during an unknown surgery, a thin black part came off during the procedure. 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 50881732 ↗
• MalfunctionSep 21, 2026Material Integrity Problem

  It was reported that during an unknown surgery, the trocar valve was damaged and there was resistance when inserting and removing forceps. No pieces fell into the patient. Another device was used to complete the case because the resistance suddenly increased. There were no adverse consequences to the patient. No further information is available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50846162 ↗
• MalfunctionSep 11, 2026Material Integrity Problem

  It was reported that during an Unknown procedure the Universal hap loose & trocar loosened. It was reported that during the surgery, universal hap loosened. Besides, the trocar was found to be loose. 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 50734093 ↗
• MalfunctionApr 23, 2026Material Integrity Problem

  IT WAS REPORTED THAT, DURING AN UNKNOWN SURGERY, DURING FORCEPS INSERTION, THE VALVE DETACHED AND ENTERED THE PATIENT¿S ABDOMINAL CAVITY ATTACHED TO THE TIP OF THE FORCEPS. THE VALVE WAS RETRIEVED, AND THE PROCEDURE WAS CONTINUED USING ANOTHER DEVICE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24971685 ↗
• MalfunctionApr 13, 2026Gas/Air Leak; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE INTERNAL SEAL WAS BROKEN, AND THE DEVICE COULD NOT INSUFFLATE AIR INTO THE ABDOMINAL CAVITY. THE PIECES WERE RETRIEVED. 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 24865778 ↗
• MalfunctionApr 13, 2026Gas/Air Leak; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE INTERNAL SEAL WAS BROKEN, AND THE DEVICE COULD NOT INSUFFLATE AIR INTO THE ABDOMINAL CAVITY. THE PIECES WERE RETRIEVED. 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 24865704 ↗
• MalfunctionApr 9, 2026Material Integrity Problem

  IT WAS REPORTED THAT, DURING AN UNKNOWN LAPAROSCOPIC SURGERY, EVEN AFTER UNLOCKING, THE OUTER SEAL COULD NOT BE 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 24834910 ↗
• MalfunctionMar 5, 2026Material Integrity Problem

  IT WAS REPORTED THAT, AFTER AN UNKNOWN SURGERY, THE CUSTOMER NOTICED THAT THE RUBBER INSIDE HAD COME OFF, SO THEY ASKED THE SALES REP TO SEE IF IT WAS A DEFECTIVE PRODUCT. IT HAS NOT BEEN LEFT INSIDE THE PATIENT'S BODY. ADDITIONAL SUTURE WAS PERFORMED 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 24523707 ↗
• MalfunctionJan 15, 2026Crack

  IT WAS REPORTED THAT, DURING AN UNKNOWN SURGERY, THE VALVE WAS BROKEN DURING USE. NO PIECES WERE LEFT INSIDE THE PATIENT. 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 24081282 ↗
• MalfunctionJan 13, 2026Material Integrity Problem

  IT WAS REPORTED THAT DURING THE UNK SURGERY, UNIVERSAL HAP LOOSE. 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 24058144 ↗
• MalfunctionOct 6, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, PART OF THE SEAL FELL OFF INTO THE ABDOMINAL CAVITY AND INSUFFLATION AIR WAS NO LONGER POSSIBLE WHEN INSERTING THE HALF GAUZE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23220404 ↗
• MalfunctionJun 2, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A ROBOT-ASSISTED GASTRECTOMY, THE DUCKBILL VALVE CAME OFF WHEN INSERTING A SILICONE DISK FROM 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 22123524 ↗
• MalfunctionMay 30, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A ROBOTIC DISTAL PANCREATECTOMY (RDP), THE OUTER SEAL WAS DAMAGED WHEN USING B12SRT. THE DAMAGED SITE HAS BEEN RETRIEVED. THERE WAS NO EFFECT ON THE PATIENT. 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 22113497 ↗
• MalfunctionMay 15, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOW ANTERIOR RESECTION OF RECTUM, WHEN THE FORCEPS WERE INSERTED FROM THE PORT, THE BLACK OUTER SEAL INSIDE THE OUTER SLEEVE FELL OFF INTO THE ABDOMINAL CAVITY. THE EVENT OCCURRED ABOUT AN HOUR AND A HALF AFTER THE SURGERY STARTED. UNTIL THEN, THERE HAD BEEN NO OPERATIONS SUCH AS FORCIBLY INSERTING THE GAUZE FROM THAT PORT. THE FALLEN PART WAS IMMEDIATELY RETRIEVED, AND NO OTHER PARTS REMAINED INSIDE THE BODY. NO ADDITIONAL RESECTION WAS REQUIRED FOR RETRIEVAL. 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 22027816 ↗
• MalfunctionApr 23, 2025Manufacturing, Packaging or Shipping Problem; Material Integrity Problem; Manufacturing, Packaging or Shipping Problem; Material Integrity Problem

  IT WAS REPORTED THAT WHEN OPENED THE PACKAGE OF THE TROCAR, THE OUTER SEAL CAME OFF AND THE DEVICE FELL TO THE FLOOR, SO IT BECAME UNCLEAN. 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 21894699 ↗
• MalfunctionApr 21, 2025Crack; Crack

  IT WAS REPORTED THAT DURING A ROBOT-ASSISTED ESOPHAGECTOMY, DEVICE HAD BEEN INSERTED INTO INTERCOSTAL SPACE, BUT THE DEVICE WAS BROKEN WHEN THE PORT WAS REMOVED. THERE WAS NO EFFECT ON THE PATIENT. 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 21877773 ↗
• MalfunctionFeb 18, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT, DURING A ROBOT ASSISTED UNKNOWN SURGERY, THE VALVE CAME OFF DURING USE. 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 21399936 ↗
• MalfunctionJan 16, 2025Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, A FOREIGN MATTER WAS FOUND INSIDE THE SEALED PACKAGE BEFORE THE STERILIZED 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 21175481 ↗
• MalfunctionJan 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, TROCAR WAS BROKEN. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21164191 ↗
• MalfunctionNov 19, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING LAPAROSCOPIC GASTRECTOMY, ABDOMINAL AIR WAS NOT MADE, SO THE TROCAR WAS CHECKED, AND IT WAS FOUND THAT THE VALVE WAS DAMAGED. IT MIGHT HAVE OCCURRED WHEN THE DOCTOR HAD PULLED THE GAUZE, AND THE VALVE WAS SNAGGED, AND IT GOT DAMAGED. 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 20729871 ↗
• MalfunctionOct 23, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC COLECTOMY, THE VALVE WAS BROKEN, AND IT COULD NOT BE USED. THE DEVICE WAS USED ON A COLON. 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 20518172 ↗
• MalfunctionOct 15, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING LAPAROSCOPIC GASTRECTOMY, WHEN A SILICONE DISC WAS INSERTED THROUGH THE 12MM PORT, THE VALVE INSIDE DEVIATED INTO THE ABDOMINAL CAVITY. THE PART WAS IMMEDIATELY RETRIEVED, BUT THE PORT COULD NOT BE REPAIRED OUTSIDE THE BODY, AND AN ADDITIONAL PORT WAS EVENTUALLY USED. THE DEVICE WAS USED ON ABDOMINAL WALL. THERE WAS NO BLEEDING. NO PIECES WERE LEFT INSIDE THE PATIENT. 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 20452085 ↗
• MalfunctionSep 24, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A HERNIA REPAIR, THE VALVE CAME OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THE VALVE WAS BROKEN OUTSIDE OF THE PATIENT, THERE WAS NO PRODUCT INSIDE OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20291052 ↗
• MalfunctionSep 18, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE VALVE CAME OFF. 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 20252141 ↗
• MalfunctionAug 6, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A ROBOT ASSISTED A PANCREATECTOMY, THE VALVE DROPPED OFF FROM THE BEGINNING. 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 19917859 ↗