Padlock Clip Pro-Select C913131 (UDI 00816765013809)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00816765013809), received between Jan 3, 2018 and Dec 19, 2019 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Material Protrusion/Extrusion” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2019Material Protrusion/Extrusion

  THE DISTRIBUTOR REPORTED THAT DURING INTUBATION OF AN ENDOSCOPE WITH A PADLOCK CLIP PRO SELECT DEFECT CLOSURE SYSTEM ATTACHED, THE USER NOTED BLOOD IN THE ESOPHAGUS AND WITHDREW THE ENDOSCOPE. UPON WITHDRAWAL OF THE DEVICE, THE USER NOTED THE POINTS OF THE CLIP WERE PROTRUDING PAST THE DEPLOYMENT HOUSING. THE PROCEDURE WAS STOPPED DUE TO THE REPORTED EVENT AND WAS COMPLETED AT A LATER DATE WITH ANOTHER PADLOCK CLIP DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9492147 ↗
• InjuryJul 2, 2019Inadequate User Interface

  DURING A PROCEDURE TO CLOSE A DEFECT IN THE SIGMOID COLON, THE USER INADVERTENTLY GATHERED TOO MUCH TISSUE WHEN POSITIONING A CLIP DEVICE NOT MANUFACTURED BY US ENDOSCOPY, WHICH RESTRICTED THE SIGMOID COLON. THE FIRST CLIP DEVICE WAS REMOVED, AND THE USER CONTINUED THE PROCEDURE WITH THE US ENDOSCOPY PADLOCK CLIP DEVICE AND AGAIN INADVERTENTLY GATHERED TOO MUCH TISSUE INTO THE CLIP AND RESTRICTED THE SIGMOID COLON. SURGICAL INTERVENTION WAS THEN REQUIRED TO REMOVE THE PADLOCK CLIP AND CLOSE THE DEFECT.

  Patient problems: No Code Available

  MAUDE report 8754867 ↗
• MalfunctionApr 16, 2019Activation, Positioning or Separation Problem

  THE USER FACILITY REPORTED THAT, DURING A PROCEDURE TO CLOSE AN ESOPHAGEAL FISTULA, A PADLOCK PRO-SELECT DEFECT CLOSURE DEVICE FAILED TO DEPLOY. A COVERED STENT WAS PLACED TO CLOSE THE FISTULA INSTEAD, NECESSITATING A FUTURE PROCEDURE TO REMOVE SAID STENT. THE PATIENT IS REPORTED TO BE DOING WELL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8520706 ↗
• MalfunctionFeb 7, 2019Detachment of Device or Device Component

  THE USER FACILITY REPORTED THE DEPLOYMENT HOUSING OF THE PADLOCK CLIP DEVICE BECAME DETACHED FROM THE ENDOSCOPE DURING WITHDRAWAL OF THE ENDOSCOPE. THE DEPLOYMENT HOUSING WAS RETRIEVED USING A RIGID ENDOSCOPE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8318187 ↗
• MalfunctionSep 27, 2018Material Separation

  THE USER FACILITY REPORTED THAT, FOLLOWING USAGE IN A PROCEDURE, THE PADLOCK DEVICE DELIVERY COMPONENT SEPARATED FROM THE END OF THE ENDOSCOPE. A GRASPING DEVICE WAS USED TO RETRIEVE THE DELIVERY COMPONENT AND THERE WAS NO REPORT OF HARM TO THE PATIENT OR USER DUE TO THE COMPONENT SEPARATION NOR RETRIEVAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7915969 ↗
• MalfunctionJun 29, 2018Positioning Failure; Material Protrusion/Extrusion

  THE USER FACILITY REPORTED THAT A PADLOCK CLIP FAILED TO FULLY DEPLOY DURING PROCEDURAL USE. THE DEVICE WAS REMOVED FROM THE PATIENT WITH THE TIPS OF THE CLIP COMPONENT PROTRUDING FROM THE DELIVERY SYSTEM HOUSING. THERE WAS NO REPORT OF HARM TO THE PATIENT OR USER AND THE PROCEDURE WAS COMPLETED WITH A SECOND PADLOCK CLIP DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7652353 ↗
• MalfunctionJan 3, 2018Positioning Failure

  THE USER FACILITY REPORTED DURING A PROCEDURE THE PADLOCK PROSELECT CLIP DID NOT FULLY DEPLOY INTO THE TISSUE. THE CLIP WAS RELEASED INTO THE LUMEN OF THE PATIENT'S COLON AND THEN THE PHYSICIAN RETRIEVED THE CLIP WITHOUT ISSUE. THERE WAS NO HARM TO THE PATIENT OR THE USER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7161820 ↗

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