Single Use Repositionable Clip HX-202LR (UDI 04953170345142)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04953170345142), received between Oct 3, 2019 and Feb 2, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED ENDOLUMINAL VACUUM CLOSURE OF A DUODENAL PERFORATION¿, A PATIENT EXPERIENCED PERFORATION ON POST-OPERATIVE DAY ONE AFTER CLOSURE OF A MUCOSAL DEFECT (USING AN OLYMPUS COAGRASPER, AND 12 QUICKCLIP PRO ENDOCLIPS) CAUSED BY AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE OF A 35MM POLYPOID LESION ON THE POSTERIOR WALL OF THE SECOND PORTION OF THE DUODENUM. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS DEVICE: COAGRASPER. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS DEVICE: QUICKCLIP PRO ENDOCLIPS. THIS LITERATURE WAS A CASE REPORT OF ONE PATIENT WHO UNDERWENT AN ENDOSCOPIC MUCOSAL RESECTION (EMR PROCEDURE OF A 35MM POLYPOID LESION ON THE POSTERIOR WALL OF THE SECOND PORTION OF THE DUODENUM. THIS WAS COMPLICATED BY INTRA-PROCEDURAL BLEEDING OF 250ML BLOOD LOSS. BLOOD LOSS WAS STOPPED WITH THE USE OF EPINEPHRINE INJECTION, AND A COAGRASPER. THE MUCOSAL DEFECT WAS THEN CLOSED WITH 12 QUICKCLIP PRO ENDOCLIPS. THE PATIENT DEVELOPED EVIDENCE OF PERFORATION ON POST-OPERATIVE DAY ONE. THE PATIENT WAS TAKEN BACK TO SURGERY ON THIS DAY AND THE AREA WAS IRRIGATED AND WIDELY DRAINED. PERFORATION CLOSURE WAS NOT ATTEMPTED AT THIS TIME DUE TO SEVERE THICKENING A

  Patient problems: Perforation

  MAUDE report 13424185 ↗
• InjuryFeb 2, 2022Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED ¿ENDOLUMINAL VACUUM CLOSURE OF A DUODENAL PERFORATION,¿ A PATIENT EXPERIENCED PERFORATION ON POST-OPERATIVE DAY ONE AFTER CLOSURE OF A MUCOSAL DEFECT (USING AN OLYMPUS COAGRASPER, AND 12 QUICKCLIP PRO ENDOCLIPS) CAUSED BY AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE OF A 35MM POLYPOID LESION ON THE POSTERIOR WALL OF THE SECOND PORTION OF THE DUODENUM. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS DEVICE: COAGRASPER. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS DEVICE: QUICKCLIP PRO ENDOCLIPS. THIS LITERATURE WAS A CASE REPORT OF ONE PATIENT WHO UNDERWENT AN ENDOSCOPIC MUCOSAL RESECTION (EMR PROCEDURE OF A 35MM POLYPOID LESION ON THE POSTERIOR WALL OF THE SECOND PORTION OF THE DUODENUM. THIS WAS COMPLICATED BY INTRA-PROCEDURAL BLEEDING OF 250ML BLOOD LOSS. BLOOD LOSS WAS STOPPED WITH THE USE OF EPINEPHRINE INJECTION, AND A COAGRASPER. THE MUCOSAL DEFECT WAS THEN CLOSED WITH 12 QUICKCLIP PRO ENDOCLIPS. THE PATIENT DEVELOPED EVIDENCE OF PERFORATION ON POST-OPERATIVE DAY ONE. THE PATIENT WAS TAKEN BACK TO SURGERY ON THIS DAY AND THE AREA WAS IRRIGATED AND WIDELY DRAINED. PERFORATION CLOSURE WAS NOT ATTEMPTED AT THIS TIME DUE TO SEVERE THICKENING

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 13424165 ↗
• MalfunctionOct 3, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE MANUFACTURER WAS INFORMED THAT DURING THE MIDDLE OF A THERAPEUTIC ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE, THE CLIP WAS EXTENDED OUT OF THE SHEATH FOR THE FIRST TIME WHEN THE WHOLE CLIP AND SPRING REPORTEDLY CAME OFF IN AN OPEN POSITION AND FELL INTO THE PATIENT'S STOMACH. THE CLIP WAS NOT RETRIEVED FROM THE PATIENT AND THE PROCEDURE WAS ABLE TO BE COMPLETED USING A DIFFERENT CLIP. UNEXPECTED BLEEDING DID NOT OCCUR AS A RESULT OF THIS EVENT. THERE WAS NO PATIENT INJURY REPORTED AND THE PATIENT IS DOING FINE.THE SCOPE AND CLIPS WERE INSPECTED PRIOR TO USE AND NO ABNORMALITIES WERE DETECTED.

  Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient

  MAUDE report 9151338 ↗