Padlock Clip 00713229Recalls & reported problems
US Endoscopy · The Padlock Clip EFTR Kit includes the EFTR Device, Raptor grasping device, and TouchSoft Coagulator Probe. It is designed for use in a flexible endoscope intended for the diagnostic tissue acquisition and full-thickness resection through the removal of lesions in the colon and rectum. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00724995226732), received between Oct 31, 2024 and Aug 7, 2026 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Activation 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.
Reports received per month
Most reported problems
Device problems
- Activation Problem3
- Adverse Event Without Identified Device or Use Problem3
- Failure to Cut2
- Device Difficult to Setup or Prepare1
- Sparking1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Pain2
- Bowel Burn1
- Burn(s)1
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 7, 2026Sparking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50175373 ↗MalfunctionJun 4, 2026Adverse Event Without Identified Device or Use Problem
THE USER FACILITY REPORTED THAT FOLLOWING A COMPLETED PROCEDURE THAT UTILIZED THE PADLOCK CLIP EFTR KIT, THE PATIENT CAME BACK WITH BLOOD FROM THE VESSEL AT THE CLIP LOCATION. THE VESSEL WAS TREATED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25394905 ↗MalfunctionMay 21, 2026Device Difficult to Setup or Prepare
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, USER FACILITY PERSONNEL EXPERIENCED DIFFICULTY WITH THE SNARE FOLLOWING DEPLOYMENT OF THE PADLOCK CLIP. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25243227 ↗MalfunctionFeb 5, 2026Adverse Event Without Identified Device or Use Problem
THE USER FACILITY REPORTED FOLLOWING USE OF THEIR PADLOCK CLIP EFTR KIT A "SUPERFICIAL THERMAL INJURY TO THE MUCOSA" WAS OBSERVED ON THE LUMEN WALL OPPOSITE THE RESECTION SITE. NO MEDICAL TREATMENT ADMINISTERED. NO REPORT OF DELAY.
Patient problems: Burn(s)
MAUDE report 24270738 ↗MalfunctionDec 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE USER FACILITY REPORTED THAT FOLLOWING A PATIENT PROCEDURE INVOLVING A PADLOCK CLIP EFTR KIT, THE PATIENT EXPERIENCED PAIN AND BLEEDING. THE PATIENT RECEIVED ADDITIONAL MEDICAL TREATMENT AND IS DOING WELL.
Patient problems: Pain
MAUDE report 23728846 ↗MalfunctionSep 19, 2025Failure to Cut; Failure to Cut
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THE PADLOCK CLIP EFTR KIT WOULD NOT DEPLOY. THE DOCTOR ELECTED TO LEAVE THE TISSUE WITHOUT DOING A RESECTION. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23095276 ↗MalfunctionSep 18, 2025Activation Problem; Activation Problem
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THE SNARE TO THEIR PADLOCK CLIP EFTR DEVICE DID NOT DEPLOY PROPERLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A DIFFERENT SNARE. NO REPORT OF INJURY OR PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23084232 ↗MalfunctionJul 25, 2025Failure to Cut; Failure to Cut
THE USER FACILITY REPORTED THAT THE SNARE TO THEIR PADLOCK CLIP EFTR KIT DID NOT FULLY RESECT THE TISSUE. TWO DIFFERENT SNARES AND FORCEPS WERE UTILIZED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY FOLLOWING A SHORT DELAY. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22612552 ↗MalfunctionJun 27, 2025Activation Problem; Activation Problem
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THE SNARE TO THEIR PADLOCK CLIP EFTR DEVICE DID NOT DEPLOY PROPERLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A DIFFERENT HOT SNARE. NO REPORT OF INJURY OR PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22349847 ↗MalfunctionOct 31, 2024Use of Device Problem; Activation Problem; Use of Device Problem; Activation Problem
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE WHICH INCLUDED USE OF THE PADLOCK CLIP EFTR DEVICE, THE TISSUE DID NOT RESECT AS INTENDED. THE DOCTOR REPORTED THERE WAS NO SERIOUS INJURY TO THE PATIENT, HOWEVER THERE WAS A MILD THERMAL INJURY ON THE OPPOSITE WALL AND CLIPS WERE PROPHYLACTICALLY PLACED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A REPLACEMENT SNARE.
Patient problems: Bowel Burn; Pain
MAUDE report 20584682 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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