AdvanCE 00711144 (UDI 00724995183608)Recalls & reported problems
US Endoscopy · The disposable AdvanCE capsule endoscope delivery device is a 2.5mm single sheathed device indicated for transendoscopic delivery of Capsules (with the dimensions of 10.5mm - 11.5mm in diameter and 23.5mm - 26.5mm 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. · Class 2
Quick summary
This US Endoscopy AdvanCE capsule endoscope delivery device delivers capsules to the stomach or duodenum. The 40 adverse event reports are malfunctions that mostly describe the device breaking, detaching, or failing to deploy or advance during procedures, sometimes causing delays but no deaths and no injuries. There are no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 40
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00724995183608), received between May 27, 2021 and Aug 7, 2026 — classified as 40 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (9 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.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information9
- Detachment of Device or Device Component6
- Break5
- Failure to Advance3
- No Apparent Adverse Event3
- Activation Problem2
- Failure to Fire2
- Separation Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions34
- Insufficient Information2
- Discomfort1
- Laceration(s)1
- Laceration(s) of Esophagus1
- Pain1
Recent adverse event reports
The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 7, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50175637 ↗MalfunctionAug 6, 2026Failure to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50160946 ↗MalfunctionJul 9, 2026
PILL CAM DEPLOYMENT DEVICE BROKE INSIDE PATIENT, NO INJURY OR EFFECT TO PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25762197 ↗MalfunctionDec 31, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
THE DISTRIBUTOR REPORTED THAT DURING A PATIENT PROCEDURE THE HANDPIECE OF THEIR ADVANCE CAPSULE ENDOSCOPE DELIVERY DEVICE BROKE RESULTING IN A PROCEDURE DELAY. THIS RESULTED IN FOUR SEPARATE ENDOSCOPE DEPLOYMENTS CAUSING THROAT IRRITATION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: Discomfort
MAUDE report 23935898 ↗MalfunctionDec 5, 2025Failure to Advance; Failure to Advance
THE USER FACILITY REPORTED THAT TWO OF THEIR ADVANCE DELIVERY DEVICES DID NOT DEPLOY. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23729115 ↗MalfunctionNov 14, 2025Ejection Problem; Ejection Problem
THE USER FACILITY REPORTED THAT THEIR ENDOSCOPE CAPSULE DETACHED FROM THE ADVANCE CAPSULE ENDOSCOPE DELIVERY DEVICE CAUSING THE CAPSULE TO GO DOWN THE THROAT OF THE PATIENT. THE CAPSULE WAS RETRIEVED, AND A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23555898 ↗MalfunctionOct 24, 2025Failure to Fire; Failure to Fire
THE USER FACILITY REPORTED THAT DURING PATIENT PROCEDURES, THE HANDLE TO THEIR ADVANCE CAPSULE ENDOSCOPE DELIVERY DEVICE BROKE CAUSING THE DEVICE TO MISFIRE THE CAPSULE. THE PROCEDURES WERE COMPLETED SUCCESSFULLY FOLLOWING A DELAY. NO REPORT OF INJURIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23381391 ↗MalfunctionAug 8, 2025Failure to Eject; Failure to Eject
THE USER FACILITY REPORTED VIA MEDWATCH REPORT (B)(4) THAT DURING A PATIENT PROCEDURE THEIR ADVANCE DELIVERY DEVICE DID NOT DEPLOY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY FOLLOWING A SHORT DELAY. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22750988 ↗MalfunctionJul 7, 2025Difficult to Remove; Separation Problem; Difficult to Remove; Separation Problem
THE USER FACILITY REPORTED VIA VIGILANCE REPORT THAT DURING A PATIENT PROCEDURE THE CAPSULE CUP THAT DEPLOYS THE CAMERA FROM THE ADVANCE ENDOSCOPE DELIVERY DEVICE BROKE IN HALF AND HAD TO BE RETRIEVED FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22411684 ↗MalfunctionMay 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED THREE ADVANCE CAPSULE ENDOSCOPE DELIVERY DEVICES DID NOT DEPLOY PROPERLY DURING PATIENT PROCEDURES. IN ONE OF THE PROCEDURES, THE CAPSULE DETACHED AND HAD TO BE RETRIEVED. THE PROCEDURES WERE COMPLETED SUCCESSFULLY UTILIZING AN ADDITIONAL ADVANCE CAPSULE ENDOSCOPE DELIVERY DEVICE. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22079090 ↗MalfunctionMay 2, 2025Detachment of Device or Device Component; Separation Problem; Detachment of Device or Device Component; Separation Problem
THE DISTRIBUTOR REPORTED THAT DURING A PATIENT PROCEDURE, THE CAPSULE CUP REMAINED ATTACHED TO THE PILL CAMERA WHEN THE PILL CAMERA WAS DEPLOYED. A ROTH NET RETRIEVAL DEVICE WAS USED TO RETRIEVE THE DEVICE. NO REPORT OF PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21953614 ↗MalfunctionApr 3, 2025Failure to Advance; Failure to Advance
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THEIR ADVANCE DELIVERY DEVICE DID NOT DEPLOY. THE PROCEDURE WAS COMPLETED BY HAVING THE PATIENT SWALLOW THE PILL CAM INSTEAD. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21766207 ↗MalfunctionJan 16, 2025No Apparent Adverse Event; No Apparent Adverse Event
THE USER FACILITY REPORTED VIA MEDWATCH (B)(4) THAT DURING A PATIENT PROCEDURE, THEIR ADVANCE CAPSULE ENDOSCOPE DELIVERY DEVICE DID NOT DEPLOY. ANOTHER DEVICE WAS UTILIZED, AND THE PATIENT PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21172820 ↗MalfunctionNov 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THEIR ADVANCE CAPSULE DELIVERY DEVICE WOULD NOT DEPLOY THE PILL CAMERA. USER FACILITY PERSONNEL STATED THAT THE PATIENT RECEIVED A SCRATCH IN THEIR ESOPHAGUS AND THE PROCEDURE WAS SUBSEQUENTLY ABORTED. NO ADDITIONAL MEDICAL TREATMENT WAS ADMINISTERED.
Patient problems: Pain
MAUDE report 20691467 ↗MalfunctionOct 22, 2024Break; Break
THE USER FACILITY REPORTED VIA VIGILANCE REPORT THAT THEIR ADVANCE ENDOSCOPE DELIVERY DEVICE IS NOT PERFORMING ITS FUNCTION CORRECTLY AND SPLIT INTO TWO PIECES. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20507224 ↗MalfunctionOct 17, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE USER FACILITY REPORTED VIA MEDWATCH REPORT (B)(4) THAT DURING A PATIENT PROCEDURE WHILE USING THEIR ADVANCE CAPSULE ENDOSCOPE DELIVERY DEVICE, THE WIRE THAT DEPLOYS THE PILL CAM BECAME STUCK BETWEEN THE SLOTS OF THE CAPSULE CUP PREVENTING THE CAMERA FROM DEPLOYING. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20474692 ↗MalfunctionOct 11, 2024Expulsion; Expulsion
THE USER FACILITY REPORTED VIA MEDWATCH REPORT (B)(4) THAT DURING A PATIENT PROCEDURE THE CAPSULE CUP THAT DEPLOYS THE CAMERA FROM THE ADVANCE ENDOSCOPE DELIVERY DEVICE FELL OFF INTO THE PATIENT. THE GASTROINTESTINAL TEAM CONFIRMED THE PATIENT HAD NATURALLY PASSED THE PLASTIC DEVICE. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20434887 ↗MalfunctionSep 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED DURING A PATIENT PROCEDURE WHILE USING THEIR ADVANCE CAPSULE ENDOSCOPE DELIVERY DEVICE THE PILL CAM HOLDER BECAME DETACHED WHEN DELIVERING THE PILL CAM AND FELL INTO THE PATIENT. THE PILL CAM HOLDER WAS RETRIEVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY. A SHORT PROCEDURE DELAY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20321152 ↗MalfunctionSep 20, 2024
DEVICE ASSEMBLED THROUGH EGD SCOPE TO DELIVER PILLCAM INTO THE DUODENUM UNDER ANESTHESIA. WHEN ATTEMPTING TO DEPLOY THE PILLCAM, THE HEAVY WIRE WHICH WAS MEANT TO PUSH THE CAPSULE OUT OF THE HOLDER INSTEAD PUSHED BETWEEN TWO OF THE PLASTIC FINGERS HOLDING THE CAPSULE TO THE END OF THE EGD SCOPE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20266558 ↗MalfunctionSep 6, 2024No Apparent Adverse Event; No Apparent Adverse Event
THE USER FACILITY REPORTED VIA MEDWATCH # (B)(4) THAT THEIR ADVANCE - CAPSULE ENDOSCOPE DELIVERY DEVICE WOULD NOT THREAD PROPERLY. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20156788 ↗MalfunctionAug 21, 2024Break; Break
THE USER FACILITY REPORTED DURING A PATIENT PROCEDURE THAT THE CAPSULE CUP BROKE APART INTO THE PATIENT FROM THEIR ADVANCE ENDOSCOPE DELIVERY DEVICE AND HAD TO BE RETRIEVED USING A LARYNGOSCOPE AND MAGILL FORCEPS. THE REPORTED EVENT RESULTED IN THE PROCEDURE BEING CANCELLED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20020134 ↗MalfunctionJun 13, 2024Insufficient Device Problem Information; Activation Problem; Insufficient Device Problem Information; Activation Problem
THE DISTRIBUTOR REPORTED THAT DURING A PATIENT PROCEDURE THEIR ADVANCE CAPSULE ENDOSCOPE DELIVERY DEVICE DID NOT DEPLOY THE CAPSULE. USER FACILITY PERSONNEL UTILIZED A SECOND ADVANCE CAPSULE ENDOSCOPE DELIVERY DEVICE AND THE CAPSULE DEPLOYED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY FOLLOWING A DELAY. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19534329 ↗MalfunctionJun 4, 2024Break; Break
THE USER FACILITY REPORTED THAT THE CAPSULE CUP OF THEIR ADVANCE CAPSULE ENDOSCOPE DELIVERY DEVICE BROKE OFF AND FELL INTO A PATIENT. THE PIECE WAS RETRIEVED SUCCESSFULLY WITH A SNARE, AND THE PROCEDURE WAS COMPLETED. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19459954 ↗MalfunctionApr 5, 2024Break; Break
THE USER FACILITY REPORTED THAT TWO ADVANCE CAPSULE ENDOSCOPE DELIVERY DEVICES BROKE DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WAS REPORT OF PROCEDURE DELAY. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19051126 ↗MalfunctionApr 4, 2024Break; Break
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE TWO OF THEIR ADVANCE CAPSULE ENDOSCOPE DELIVERY DEVICES "BROKE" WHILE ATTEMPTING TO DELIVER THE PILL CAPSULE. USER FACILITY PERSONNEL WERE ABLE TO SUCCESSFULLY DELIVER THE PILL CAPSULE WITH A THIRD DEVICE. THE PATIENT PROCEDURE WAS COMPLETED SUCCESSFULLY FOLLOWING A DELAY. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19042624 ↗
Other SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE devices
- CapsoCam Plus SV-3Capsovision, Inc. · System, Imaging, Gastrointestinal, Wireless, Capsule1 recall0 reports
- PillCam FGS-0501Given Imaging, Inc. · SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE27 reports
- PillCam FGS-0391Given Imaging, Inc. · SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE2 deaths17 reports
- Pillcam FGS-0109Given Imaging, Inc. · SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE13 reports
- PillCam FGS-0400Given Imaging, Inc. · SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE11 reports
- AdvanCE 00711144US Endoscopy · SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE10 reports
- Pillcam FGS-0347Given Imaging, Inc. · SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE1 death10 reports
- Pillcam FGS-0497Given Imaging, Inc. · SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE9 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.