Padlock Clip C910001 (UDI 00816765013793)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00816765013793), received between Dec 1, 2017 and Oct 14, 2020 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Activation Problem” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K120814, K180689); they may or may not involve this specific model.

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 14, 2020Defective Component

  THE USER FACILITY REPORTED INCOMPLETE DEPLOYMENT OF A PADLOCK CLIP DEFECT CLOSURE DEVICE DURING A PATIENT PROCEDURE, AND THE USER UTILIZED FORCEPS TO ASSIST DEPLOYMENT. THE CLIP WAS DEPLOYED SUCCESSFULLY, THE PROCEDURE WAS COMPLETED, AND NO HARM TO THE PATIENT OR USER WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 10680065 ↗
• MalfunctionJun 26, 2020Failure to Advance; Material Protrusion/Extrusion

  THE USER FACILITY REPORTED THAT DURING INTUBATION OF AN ENDOSCOPE WITH A PADLOCK CLIP DEFECT CLOSURE SYSTEM ATTACHED, THE USER WAS UNABLE TO ADVANCE PAST THE UPPER ESOPHAGEAL SPHINCTER. UPON WITHDRAWAL OF THE DEVICE, THE USER NOTED THE POINTS OF THE CLIP WERE PROTRUDING PAST THE DEPLOYMENT HOUSING. THE USER REPORTED LOCAL TRAUMA TO THE PATIENT'S OROPHARYNX WITH NO TREATMENT REQUIRED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER PADLOCK DEVICE.

  Patient problems: Injury

  MAUDE report 10200759 ↗
• MalfunctionApr 10, 2020Device Fell; Activation Problem

  A USER FACILITY REPORTED THROUGH THE DISTRIBUTOR IN (B)(6) THAT A PADLOCK CLIP DEFECT CLOSURE SYSTEM DID NOT FULLY DEPLOY, AND THE CLIP SUBSEQUENTLY DROPPED FROM THE DEPLOYMENT HOUSING INTO THE PATIENT'S STOMACH. THE CLIP WAS IMMEDIATELY RETRIEVED USING A RAPTOR GRASPING DEVICE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A SECOND PADLOCK CLIP DEVICE. NO HARM TO THE PATIENT OR USER WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9948320 ↗
• MalfunctionDec 13, 2019Activation Problem

  THE USER FACILITY REPORTED THE PADLOCK CLIP FAILED TO DEPLOY DURING USE IN A PROCEDURE TO CLOSE A FISTULA. THE CLIP WAS RELEASED INTO THE PATIENT'S STOMACH AND RETRIEVED WITH A RAPTOR GRASPING FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER PADLOCK CLIP DEVICE. THERE WAS NO REPORT OF INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9466462 ↗
• MalfunctionNov 27, 2019Material Protrusion/Extrusion; Activation Problem

  THE DISTRIBUTOR REPORTED THE CLIP COMPONENT WAS NOT FULLY DEPLOYED DURING USE OF THE PADLOCK CLIP DEFECT CLOSURE SYSTEM, NECESSITATING DEVICE WITHDRAWAL WITH THE CLIP PRONGS PARTIALLY PROTRUDING FROM THE DELIVERY HOUSING. SCRATCHES WERE DETECTED ON THE ESOPHAGUS HOWEVER NO TREATMENT WAS REQUIRED. THE PROCEDURE WAS COMPLETED WITH A SECOND PADLOCK CLIP DEFECT CLOSURE SYSTEM.

  Patient problems: No Code Available

  MAUDE report 9382743 ↗
• MalfunctionMay 29, 2019Difficult to Advance

  THE USER FACILITY REPORTED DIFFICULTY PASSING THE PADLOCK DEFECT CLOSURE DEVICE THROUGH THE UPPER ESOPHAGUS DURING A PROCEDURE TO CLOSE A FISTULA. SUBSEQUENT TO INSERTION OF THE DEVICE, A LACERATION OF THE ESOPHAGUS WAS NOTED. AN INJECTION OF EPINEPHRINE WAS ADMINISTERED TO CONTROL BLEEDING AND THE FISTULA CLOSURE PROCEDURE WAS COMPLETED.

  Patient problems: Laceration(s) of Esophagus

  MAUDE report 8649819 ↗
• InjuryMar 7, 2019Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED A PERFORATION WAS DETECTED DURING USE OF THE PADLOCK CLIP DEVICE IN A POLYP RESECTION PROCEDURE. THE CLIP WAS DEPLOYED OVER A DUODENAL POLYP PRIOR TO RESECTION AND THE POLYP WAS RESECTED ABOVE THE CLIP. THE TISSUE SEPARATED FROM THE CLIP, EXPOSING THE RESECTION SITE PERFORATION. SURGICAL INTERVENTION WAS NEEDED, AND THE PATIENT HAS BEEN DISCHARGED.

  Patient problems: Perforation

  MAUDE report 8398493 ↗
• InjuryFeb 8, 2019Nonstandard Device

  THE USER FACILITY REPORTED AN ESOPHAGEAL LACERATION OCCURRED DURING A PROCEDURE IN WHICH OUR PADLOCK CLIP DEFECT CLOSURE SYSTEM WAS ONE OF THE MEDICAL DEVICES UTILIZED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE, AND THE PATIENT WAS ADMITTED TO HOSPITAL FOR OBSERVATION AND HAS SINCE BEEN DISCHARGED.

  Patient problems: Laceration(s)

  MAUDE report 8323666 ↗
• MalfunctionFeb 6, 2019Activation, Positioning or Separation Problem

  THE USER FACILITY REPORTED THE PADLOCK CLIP FAILED TO ENGAGE TISSUE. THE CLIP WAS RELEASED INTO THE STOMACH AND RETRIEVED WITH A ROTH NET. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE, AND THERE WAS NO REPORT OF INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8310432 ↗
• MalfunctionJan 4, 2019Difficult or Delayed Activation

  THE USER FACILITY REPORTED DIFFICULTY WHILE ATTEMPTING TO DEPLOY THE CLIP COMPONENT OF THE PADLOCK DEVICE DURING A HEMOSTASIS PROCEDURE. THE CLIP WAS DEPLOYED ON THE THIRD ATTEMPT; HOWEVER, THE PHYSICIAN DID NOT BELIEVE BLEEDING WAS CONTROLLED AFTER CLIP PLACEMENT AND THE PATIENT WAS SENT TO INTERVENTIONAL RADIOLOGY FOR FURTHER TREATMENT. THROUGH FOLLOW UP, US ENDOSCOPY LEARNED THE ENDOSCOPE USED IN THIS PROCEDURE WAS NOT COMPATIBLE WITH THE PADLOCK CLIP DEVICE.

  Patient problems: Blood Loss

  MAUDE report 8219054 ↗
• MalfunctionDec 1, 2017Positioning Failure

  THE USER FACILITY REPORTED DURING A HEMOSTASIS PROCEDURE TWO PADLOCK CLIPS FAILED TO DEPLOY. THE PATIENT WAS SUBSEQUENTLY SENT TO INTERVENTIONAL RADIOLOGY TO COMPLETE THE PROCEDURE AND WAS DISCHARGED THE SAME DAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7075905 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K120814, K180689. One submission often covers many models, so check the product and lot details in each record.

• Z-1011-2019 · Feb 4, 2019 · Terminated
  US Endoscopy Padlock Clip defect closure system Ref: C910001 The Padlock Clip is indicated for use in flexible endoscopy and for the compression of tissue in the gastrointestinal