Resolution Clip M00522600Recalls & reported problems

Summary

The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 08714729504764), received between Aug 24, 2017 and Feb 3, 2026 — classified as 73 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (67 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 73 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2026Premature Activation; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED TO TREAT WOUND HEMOSTASIS DURING A SPECIAL TREATMENT BY ENTEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE CLIP WAS LOCKED, BUT IT COULD NOT BE DEPLOYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP DEVICE. A PHOTO WAS SUBMITTED BY THE CUSTOMER SHOWING THE DEVICE OUTSIDE THE PATIENT, AND IT COULD BE OBSERVED THAT THE CLIP PREMATURELY DEPLOYED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24251399 ↗
• MalfunctionOct 6, 2025Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED FOR CLOSURE IN THE STOMACH DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CLIP WAS ABLE TO GRASP AND LOCK ONTO TISSUE; HOWEVER, THE CLIP COULD NOT DETACH FROM THE CATHETER TO DEPLOY. IT WAS NOTED THAT THE CLIP COULD NOT BE DEPLOYED AFTER IT WAS OPENED. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23221085 ↗
• MalfunctionSep 12, 2024Premature Activation; Adverse Event Without Identified Device or Use Problem; Premature Activation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP WAS USED FOR SURGICAL CLOSURE OF THE WOUND TO STOP BLEEDING DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) WOUND CLOSURE PROCEDURE PERFORMED ON (B)(6) 2024. DURING PREPARATION, WHEN THE PHYSICIAN OPENED THE PACKAGE, THE FRONT PART OF THE CLIP FELL OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20201441 ↗
• MalfunctionAug 21, 2024Activation, Positioning or Separation Problem; Material Twisted/Bent; Activation, Positioning or Separation Problem; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP WAS USED IN THE STOMACH FOR A GASTRIC ULCER BLEEDING DURING A GASTRIC ULCER HEMOSTASIS PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE AND INSIDE THE PATIENT, WHEN THE CLIP CAPTURED THE TISSUE AND CLOSED, THE ARMS WERE BENT AND COULD NOT BE RECAPTURED OR DEPLOYED AS EXPECTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20016489 ↗
• MalfunctionApr 17, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2024. IT WAS REPORTED THAT THE DEVICE UNABLE TO DEPLOY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19127543 ↗
• MalfunctionFeb 12, 2024Premature Activation; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP WAS USED IN THE ESOPHAGUS DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, WHEN THE CLIP WAS READY TO DEPLOY ON THE LESION, THE CLIP WAS PREMATURELY DEPLOYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18684283 ↗
• MalfunctionFeb 12, 2024Premature Activation; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP WAS USED IN THE ESOPHAGUS DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE CLIP REACHED THE LESION, BUT IT WAS DETACHED WHEN IT WAS PREPARED TO BE DEPLOYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18684238 ↗
• MalfunctionFeb 9, 2024Premature Activation; Human-Device Interface Problem; Premature Activation; Human-Device Interface Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP WAS USED IN THE ESOPHAGUS DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE CLIP DETACHED WHEN THE CLIP WAS PREPARED TO BE DEPLOYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18675674 ↗
• MalfunctionJan 12, 2024Activation, Positioning or Separation Problem; Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem; Activation, Positioning or Separation Problem; Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED IN THE STOMACH FOR A LESION DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE CLIP WAS ABLE TO GRASP AND LOCK ONTO TISSUE; HOWEVER, THE CLIP COULD NOT DETACH FROM THE CATHETER TO DEPLOY. THE PHYSICIAN ATTEMPTED TO OPEN AND CLOSE THE DEVICE, BUT WAS UNSUCCESSFUL. THE CLIP WAS BENT, AND THE JOINT AREA WAS CURVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18502476 ↗
• MalfunctionDec 11, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE CLIP COULD NOT BE DEPLOYED NORMALLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18306437 ↗
• MalfunctionSep 18, 2023Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED IN THE STOMACH DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE PERFORMED ON (B)(6), 2023. DURING THE PROCEDURE, THE CLIP WAS ABLE TO GRASP AND LOCK ONTO TISSUE; HOWEVER, THE CLIP COULD NOT DETACH FROM THE CATHETER TO DEPLOY. THE PHYSICIAN ATTEMPTED TO MOVE THE CLIP FORWARD SLIGHTLY, HOWEVER, IT WOULD NOT DETACH FROM THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17764283 ↗
• MalfunctionSep 14, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED IN THE STOMACH DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE CLIP WAS ABLE TO GRASP AND LOCK ONTO TISSUE; HOWEVER, THE CLIP WOULD NOT SEPARATE AND DEPLOY. THE PHYSICIAN TRIED PUSHING THE CLIP FORWARD, BUT IT STILL WOULD NOT DETACH. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17748024 ↗
• MalfunctionAug 30, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED IN THE STOMACH DURING AN ENDOSCOPIC TREATMENT PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE DEVICE COULD GRASP, CLOSE AND LOCK ONTO TISSUE AND WAS EVENTUALLY UNABLE TO RELEASE. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17649998 ↗
• MalfunctionAug 15, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED IN THE STOMACH DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE CLIP WAS ABLE TO GRASP AND LOCK ONTO TISSUE; HOWEVER, THE CLIP WAS UNABLE TO RELEASE FROM THE CATHETER TO DEPLOY. THE CLIP EVENTUALLY FELL OFF DURING THE ATTEMPTED DEPLOYMENT PROCESS, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17550037 ↗
• MalfunctionAug 7, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED IN THE INTESTINAL TRACT DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE CLIP WAS STUCK IN THE TIP OF THE OUTER SHEATH. THE CLIP COULD NOT DETACH FROM THE CATHETER TO DEPLOY. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17469620 ↗
• MalfunctionApr 5, 2023Use of Device Problem; Activation, Positioning or Separation Problem; Use of Device Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED IN THE ESOPHAGUS DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION ESD PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE CLIP REACHED ONTO LESION; HOWEVER, THE CLIP COULD NOT FULLY DEPLOY. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP DEVICE. NOTE: IT WAS REPORTED THAT THE SHEATH WAS COMPLETELY REMOVED OFF OF THE DEVICE. AS PER IFU, THE OVER SHEATH IS SUPPOSED TO BE RETRACTED TO EXPOSE THE CLIP AND NOT REMOVED FROM THE CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16682850 ↗
• MalfunctionMar 23, 2023Use of Device Problem; Activation, Positioning or Separation Problem; Use of Device Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED IN THE ESOPHAGUS DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE CLIP COULD NOT BE DEPLOYED. IT WAS REPORTED THAT THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP. NOTE: IT WAS REPORTED THAT THE CUSTOMER ATTEMPTED TO REMOVE THE SHEATH COMPLETELY OFF THE DEVICE. HOWEVER, PER THE INSTRUCTIONS FOR USE, THE OVER SHEATH IS SUPPOSED TO BE RETRACTED TO EXPOSE THE CLIP AND NOT REMOVED FROM THE CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16600900 ↗
• MalfunctionMar 21, 2023Activation, Positioning or Separation Problem; Difficult to Open or Close; Activation, Positioning or Separation Problem; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED IN ESOPHAGUS DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE CLIP WAS ABLE TO GRASP AND LOCK ONTO TISSUE; HOWEVER, THE CLIP WAS UNABLE TO RELEASE FROM THE CATHETER TO DEPLOY. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16584076 ↗
• MalfunctionMar 20, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED IN THE ESOPHAGUS DURING A ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE CLIP WAS ABLE TO GRASP AND LOCK THE TISSUE; HOWEVER, THE CLIP COULD NOT BE DEPLOYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16573964 ↗
• MalfunctionOct 5, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED IN THE STOMACH DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE CLIP WAS ABLE TO GRASP AND LOCK ONTO TISSUE; HOWEVER, THE CLIP COULD NOT BE RELEASED FROM THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15544111 ↗
• MalfunctionApr 11, 2022Defective Device; Activation, Positioning or Separation Problem; Material Deformation; Defective Device; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2022. DURING UNPACKING, IT WAS NOTICED THAT THE DEVICE WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDINGS OF BUSHING HOOKS WERE OUT OF SPECIFICATION AND THE BUSHING TABS WERE ROUNDED, LEADING TO A DEPLOYMENT PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14079302 ↗
• MalfunctionFeb 3, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED IN THE STOMACH DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE CLIP WAS ABLE TO GRASP AND LOCK ONTO TISSUE, BUT COULD NOT BE RELEASED FROM THE CATHETER TO DEPLOY. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13440391 ↗
• MalfunctionJan 13, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED IN STOMACH DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE CLIP COULD NOT DETACH AFTER ADVANCING FROM THE FORCEPS CHANNEL OF THE SCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13254188 ↗
• MalfunctionJan 13, 2022Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Activation, Positioning or Separation Problem; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED IN THE STOMACH DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE CLIP GRASPED AND LOCKED ONTO TISSUE AND WHEN TRYING TO DEPLOY THE CLIP, IT DID NOT RELEASE FROM THE CATHETER. ANOTHER ATTEMPT WAS MADE AND THE FRONT END OF THE CLIP DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13250519 ↗
• MalfunctionJan 4, 2022Activation, Positioning or Separation Problem; Human-Device Interface Problem; Activation, Positioning or Separation Problem; Human-Device Interface Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED IN THE STOMACH DURING AN DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE CLIP GRASPED AND LOCKED ONTO TISSUE, BUT DID NOT RELEASE FROM THE CATHETER TO DEPLOY. DURING THE DEPLOYMENT, THE FRONT END OF THE HEMOSTATIC CLIP WAS PEELED OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13158142 ↗