AdvanCERecalls & reported problems across all models
US Endoscopy · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 50
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 2 models of AdvanCE by US Endoscopy in the FDA's device registry (GUDID). Together they are named in 50 adverse event reports in the FDA's MAUDE database, received between Jan 4, 2018 and Aug 7, 2026 — classified as 50 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported AdvanCE problems
Device problems
- Detachment of Device or Device Component9
- Insufficient Device Problem Information9
- Break5
- Activation, Positioning or Separation Problem4
- Failure to Advance3
- No Apparent Adverse Event3
- Activation Problem2
- Failure to Fire2
Patient problems
- No Clinical Signs, Symptoms or Conditions34
- No Known Impact Or Consequence To Patient7
- Insufficient Information2
- Complaint, Ill-Defined1
- Discomfort1
- Hemorrhage/Blood Loss/Bleeding1
- Laceration(s)1
- Laceration(s) of Esophagus1
AdvanCE models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- AdvanCE 00711144SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE40 reports
- AdvanCE 00711144SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE10 reports
Recent AdvanCE adverse event reports
The 15 most recent reports across all models, 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 ↗
Other US Endoscopy products
All US Endoscopy devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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