AdvanCE 00711144 (UDI 00816765011188)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00816765011188), received between Jan 4, 2018 and Oct 16, 2020 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 16, 2020Detachment of Device or Device Component

  THE DISTRIBUTOR REPORTED THAT THE CAPSULE HOLDER COMPONENT OF THE ADVANCE CAPSULE ENDOSCOPE DELIVERY DEVICE BECAME DETACHED DURING DEPLOYMENT OF THE VIDEO CAPSULE. THE CAPSULE HOLDER REMAINED ATTACHED TO THE CAPSULE ENDOSCOPE, CAUSING THE VIDEO CAPSULE LENS TO BE SHADED DURING THE PROCEDURE. THE DISTRIBUTOR STATED THE EVENT MADE THE PROCEDURE MORE DIFFICULT FOR THE PHYSICIAN AND STATED THE EVENT WAS ASSOCIATED WITH PATIENT HARM. NO INTERVENTION WAS REPORTED.

  Patient problems: Complaint, Ill-Defined

  MAUDE report 10692735 ↗
• MalfunctionJan 16, 2020Material Protrusion/Extrusion

  THE USER FACILITY REPORTED THAT THAT DURING A PROCEDURE WHICH INCLUDED USE OF THE ADVANCE CAPSULE DELIVERY DEVICE, THE DEVICE FAILED TO DEPLOY THE VIDEO CAPSULE AND THE DEVICE DEPLOYMENT CABLE WAS OBSERVED PROTRUDING FROM A SLOT IN THE SIDE OF THE CAPSULE HOLDER. THE DEPLOYMENT CABLE WAS RETRACTED INTO THE CAPSULE HOLDER AND THE DEVICE WAS REMOVED WITH NO REPORT OF HARM TO THE PATIENT OR USER. THE VIDEO ENDOSCOPY WAS COMPLETED WITHOUT USE OF THE ADVANCE DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9596156 ↗
• MalfunctionApr 25, 2019Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE CAPSULE CUP PORTION OF AN ADVANCE CAPSULE DELIVERY DEVICE DETACHED FROM THE DEVICE DURING VIDEO CAPSULE DEPLOYMENT. THE CAPSULE CUP REMAINED ATTACHED TO THE VIDEO CAPSULE AND WAS ALLOWED TO PASS NATURALLY. THE PROCEDURE WAS COMPLETED AND THERE WAS NO REPORTED HARM TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8552118 ↗
• MalfunctionFeb 7, 2019Activation, Positioning or Separation Problem

  THE USER FACILITY REPORTED THAT DURING A PROCEDURE WHICH INCLUDED USE OF THE ADVANCE CAPSULE DELIVERY DEVICE, THE DEVICE FAILED TO DEPLOY THE VIDEO CAPSULE. UPON WITHDRAWAL OF THE ENDOSCOPE AND DEVICE, THE CAPSULE DEPLOYMENT CABLE WAS OBSERVED EXTENDING FROM THE SIDE OF CAPSULE HOLDER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SECOND ADVANCE DEVICE AND THERE WAS NO REPORTED HARM TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8318199 ↗
• MalfunctionFeb 7, 2019Activation, Positioning or Separation Problem

  THE USER FACILITY REPORTED THAT DURING A PROCEDURE WHICH INCLUDED USE OF THE ADVANCE CAPSULE DELIVERY DEVICE, THE DEVICE FAILED TO DEPLOY THE VIDEO CAPSULE. UPON WITHDRAWAL OF THE ENDOSCOPE AND DEVICE, THE CAPSULE DEPLOYMENT CABLE WAS OBSERVED EXTENDING FROM THE SIDE OF CAPSULE HOLDER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SECOND ADVANCE DEVICE AND THERE WAS NO REPORTED HARM TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8318188 ↗
• MalfunctionJan 16, 2019Mechanical Jam

  THE USER FACILITY REPORTED THAT, DURING WITHDRAWAL OF AN ADVANCE CAPSULE ENDOSCOPE DELIVERY DEVICE THROUGH THE ESOPHAGUS, THE DEVICE BECAME STUCK IN THE AREA OF THE PATIENT'S LARYNX. THE PHYSICIAN SUCCEEDED IN REMOVING THE DEVICE AND THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8254741 ↗
• MalfunctionSep 28, 2018Firing Problem

  THE USER FACILITY REPORTED THAT DURING A PROCEDURE WHICH INCLUDED USE OF THE ADVANCE CAPSULE DELIVERY DEVICE, THE DEVICE FAILED TO DEPLOY THE VIDEO CAPSULE. UPON WITHDRAWAL OF THE ENDOSCOPE AND DEVICE, THE CAPSULE DEPLOYMENT CABLE WAS OBSERVED EXTENDING FROM THE SIDE OF CAPSULE HOLDER. THE USER REPORTED THAT SCRAPES WERE OBSERVED IN THE ESOPHAGUS FOLLOWING THE REPORTED EVENT. NO TREATMENT WAS REQUIRED FOR THE REPORTED SCRAPES AND THE PROCEDURE WAS COMPLETED AS UPPER GI ENDOSCOPY WITHOUT USE OF A CAPSULE ENDOSCOPE.

  Patient problems: No Code Available

  MAUDE report 7920287 ↗
• MalfunctionSep 5, 2018Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE CAPSULE CUP DETACHED FROM AN ADVANCE CAPSULE DELIVERY DEVICE DURING PROCEDURAL USE. THE DETACHED PORTION WAS RETRIEVED, AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7847532 ↗
• MalfunctionMar 8, 2018Positioning Failure; Device Contamination with Body Fluid

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, THE ADVANCE CAPSULE ENDOSCOPE DELIVERY DEVICE FAILED TO DEPLOY THE VIDEO CAPSULE. THE DEVICE WAS WITHDRAWN FROM THE PATIENT'S ESOPHAGUS AND THE PATIENT WAS ABLE TO MANUALLY SWALLOW THE VIDEO CAPSULE. THE FACILITY STATED BLOOD WAS IDENTIFIED IN THE PATIENT'S ESOPHAGUS FOLLOWING THE PROCEDURE; HOWEVER, THE SOURCE OF THE BLOOD WAS NOT CONCLUSIVELY DETERMINED. THE FACILITY STATED THE AMOUNT OF BLOOD IDENTIFIED WAS NOT A "GROSS AMOUNT". THE PATIENT WAS DISCHARGED FOLLOWING THE EVENT; NO MEDICAL TREATMENT OR INTERVENTION WAS REQUIRED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 7324767 ↗
• MalfunctionJan 4, 2018Material Separation; Activation, Positioning or Separation Problem

  THE DISPOSABLE ADVANCE® CAPSULE ENDOSCOPE DELIVERY DEVICE IS A 2.5 MM SINGLE SHEATHED DEVICE INDICATED FOR TRANSENDOSCOPIC DELIVERY OF CAPSULES (WITH THE DIMENSIONS OF 10.5 MM - 11.5 MM IN DIAMETER AND 23.5 MM - 26.5 MM IN LENGTH), TO THE STOMACH OR DUODENUM. THIS DEVICE IS INTENDED FOR PATIENTS WHO ARE EITHER UNABLE TO SWALLOW THE CAPSULE, OR UNABLE TO PASS THE CAPSULE BEYOND THE PYLORUS IN SUFFICIENT TIME TO COMPLETE THE DESIRED DIAGNOSTIC EVALUATION. THE USER FACILITY REPORTED DURING A PROCEDURE THE ADVANCE CAPSULE ENDOSCOPE DELIVERY DEVICE DID NOT FULLY DEPLOY THE CAPSULE. WHILE REMOVING THE DEVICE, THE CAPSULE SEPARATED IN THE PATIENT'S MOUTH. THE CAPSULE WAS RETRIEVED DIGITALLY WITHOUT ISSUE. THERE WAS NO REPORT OF HARM TO THE PATIENT OR USER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7165641 ↗