gastroduodenal FTRD Set FTRD 13Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 04260206310655), received between Oct 30, 2023 and Nov 13, 2025 — classified as 2 deaths, 15 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (10 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryNov 13, 2025Use of Device Problem; Failure to Fire; Use of Device Problem; Failure to Fire

  THE GASTRODUODENAL FTRD WAS USED TO REMOVE A STOMACH LESION. THE CLIP WAS NOT DEPLOYED AND THE TISSUE WAS RESECTED. NO FULL THICKNESS RESECTION WAS PERFORMED AND THE MUCOSAL LESION WAS CLOSED WITH CLIPS. NO FURTHER CLINICAL INTERVENTION WAS NEEDED.

  Patient problems: Stomach Ulceration

  MAUDE report 23539763 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE GASTRODUODENAL FTRD WAS USED FOR THE TREATMENT OF A LESION IN THE STOMACH. THE INITIAL TREATMENT WAS SUCCESSFUL; THE CLIP WAS APPLIED AS INTENDED. AFTER ONE WEEK IT WAS NOTICED THAT THE CLIP HAD SUBSEQUENTLY FALLEN OFF THE TISSUE. THE RESULTING PERFORATION WAS CLOSED BY A WEDGE TREATMENT.

  Patient problems: Perforation

  MAUDE report 22370249 ↗
• InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE GASTRODUODENAL FTRD WAS USED TO TREAT A FIBROTIC LESION IN THE STOMACH. THE CLIP WAS SUCCESSFUL DEPLOYED. THE TISSUE WAS ACCIDENTALLY RESECTED AT A DIFFERENT SITE. THE RESULTING PERFORATION WAS IMMEDIATELY DETECTED AND CLOSED WITH CLIPS.

  Patient problems: Internal Organ Perforation

  MAUDE report 22025519 ↗
• InjuryMay 15, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE GASTRODUODENAL FTRD WAS USED TO TREAT A GIST IN THE STOMACH. SUCCESSFUL CLIP APPLICATION WAS NOT VERIFIED PRIOR TO TISSUE RESECTION. THE RESULTING PERFORATION WAS CLOSED WITH CLIPS WITHIN THE SAME PROCEDURE. THE PATIENT STAYED IN HOSPITAL OVERNIGHT AND RECOVERED WELL.

  Patient problems: Internal Organ Perforation

  MAUDE report 22025495 ↗
• InjuryMay 15, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE GASTRODUODENAL FTRD WAS USED TO TREAT A LESION IN THE DUODENUM. DUE TO A LARGE AMOUNT OF TISSUE MOBILIZED INTO THE CAP, THE VIEW OF THE WHITE APPLICATION RING WAS LIMITED. THE CLIP APPLICATION WAS NOT VERIFIED BEFORE TISSUE RESECTION. NO FULL THICKNESS RESECTION WAS MADE. THE RESECTION SIDE WAS CLOSED WITH A CLIP WITHIN THE SAME PROCEDURE.

  Patient problems: Laceration(s)

  MAUDE report 22025333 ↗
• InjuryMay 15, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE GASTRODUODENAL FTRD WAS USED FOR THE TREATMENT OF A DUODENAL NET. WHEN ATTEMPTING TO DEPLOY THE CLIP, THE MONITOR FROZE. THE HAND WHEEL WAS TURNED UNTIL RESISTANCE WAS FELT AND CLIP APPLICATION WAS ASSUMED, BUT NOT VISUALLY VERIFIED. THE TISSUE WAS SUBSEQUENTLY RESECTED RESULTING IN A PERFORATION. THE PERFORATION WAS CLOSED WITH MULTIPLE CLIPS AND A COVERED STENT WITHIN THE SAME PROCEDURE. THE PATIENT STAYED IN HOSPITAL FOR TWO WEEKS.

  Patient problems: Bowel Perforation

  MAUDE report 22024222 ↗
• InjuryMay 14, 2025Use of Device Problem; Use of Device Problem

  DURING AN INTERVENTION IN THE POSTERIOR WALL OF THE STOMACH CORPUS FOR TUMOR REMOVAL, CLIP DEPLOYMENT WAS MISTAKENLY ASSUMED AND RESECTION PERFORMED SUBSEQUENTLY WITHOUT VERIFYING CLIP APPLICATION BEFOREHAND. WHILE RETRIEVING THE ENDOSCOPE THE ON THE CAP REMAINING CLIP CAME OFF AT THE DISTAL END OF THE ESOPHAGUS. THE CLIP WAS SAVED WITHOUT ANY COMPLICATION. THE PERFORATION CAUSED IN THE STOMACH AND THE ESOPHAGUS COULD BE CLOSED WITH OTSC CLIP. THE PATIENT WAS HOSPITALIZED OVER THE WEEKEND FOR OBSERVATION.

  Patient problems: Internal Organ Perforation; Perforation of Esophagus

  MAUDE report 22017645 ↗
• InjuryMay 14, 2025Use of Device Problem; Use of Device Problem

  DURING AN INTERVENTION IN THE UPPER GI TRACT FOR EFTR, CLIP DEPLOYMENT WAS NOT VISUALLY VERIFIED BEFORE PERFORMING RESECTION. THE RESULTING PERFORATION WAS CLOSED WITH OTSC. THE PATIENT RECOVERED WITHOUT FURTHER TREATMENT.

  Patient problems: Internal Organ Perforation

  MAUDE report 22017622 ↗
• InjuryMar 21, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE GASTRODUODENAL FTRD WAS USED FOR THE TREATMENT OF A NET IN THE DUODENUM. CLIP APPLICATION WAS NOT VERIFIED PRIOR TO TISSUE RESECTION. THE RESULTING PERFORATION WAS CLOSED WITH CLIPS WITHIN THE SAME PROCEDURE. NO FURTHER INFORMATION ON THE PATIENT´S STATE OF HEALTH IS AVAILABLE.

  Patient problems: Bowel Perforation

  MAUDE report 21662028 ↗
• InjuryMar 21, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE GASTRODUODENAL FTRD WAS USED TO TREAT A LESION IN THE STOMACH. THE USE OF SUCTION TO MOBILISE THE TISSUE LIMITED THE VIEW OF THE APPLICATION RING. CLIP APPLICATION WAS NOT VERIFIED PRIOR TO TISSUE RESECTION. THE RESULTING PERFORATION WAS CLOSED WITH CLIPS WITHIN THE SAME PROCEDURE. THE PATIENT RECOVERED WELL.

  Patient problems: Bowel Perforation

  MAUDE report 21662027 ↗
• InjuryDec 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INITIAL GASTRODUODENAL FTRD TREATMENT IN THE STOMACH WAS SUCCESSFUL AND WITHOUT COMPLICATIONS. AFTER A FEW DAYS THE PATIENT HAD DEVELOPED ABDOMINAL PAIN. THE FTRD CLIP HAD DETACHED FROM RESECTION SITE AND PATIENT NEEDED SURGERY.

  Patient problems: Abdominal Pain; Perforation

  MAUDE report 20878349 ↗
• InjuryDec 9, 2024Use of Device Problem; Use of Device Problem

  GASTRODUODENAL FTRD WAS USED FOR THE TREATMENT OF A CARCENOID IN THE DUODENAL BULB. CLIP APPLICATION WAS NOT VISUALLY VERIFIED BY THE USER BEFORE TISSUE RESECTION. THE RESULTING PERFORATION WAS CLOSED BY SURGERY. THE PATIENT RECOVERED WELL.

  Patient problems: Bowel Perforation

  MAUDE report 20878344 ↗
• InjuryNov 15, 2024Use of Device Problem; Use of Device Problem

  GASTRODUODENAL FTRD WAS USED FOR A PLANNED RESECTION OF A LESION IN THE DUODENUM. TO ACCESS THE DUODENUM A DILATATION OF AN ESOPHAGEAL NARROWING WAS REQUIRED, DURING WHICH AN ESOPHAGEAL PERFORATION OCCURRED. THE PATIENT SUFFERED FROM ACHALASIA. THE PERFORATION WAS CLOSED BY SURGERY.

  Patient problems: Achalasia; Perforation of Esophagus

  MAUDE report 20693116 ↗
• DeathNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A SUCCESSFUL PROCEDURE IN THE STOMACH USING A GASTRODUODENAL FTRD SYSTEM SET, AN ESOPHAGEAL PERFORATION WAS CAUSED. THE PERFORATION WENT UNNOTICED, LEADING TO MEDIASTINITIS AND SEPTIC SHOCK, RESULTING IN THE PATIENT'S DEATH. THE PERFORATION WAS NOT AT THE SITE OF THE INTERVENTION ITSELF; IT WAS IN THE MID TO LOWER ESOPHAGUS. AT THE END OF THE PROCEDURE THE ENDOSCOPIST DID NOT VISUALIZE A PERFORATION; THE ELDERLY PATIENT HAD MULTIPLE COMORBID DISEASES AND IN PARTICULAR CHRONIC REFLUX AND ESOPHAGITIS WITH A MECHANICALLY VULNERABLE ESOPHAGEAL WALL.

  Patient problems: Perforation of Esophagus

  MAUDE report 20693103 ↗
• InjuryMay 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT AFTER REMOVAL OF A GIST IN THE STOMACH, THE PATIENT SUFFERED DULL PAIN THE DAY AFTER SURGERY. AFTER 10 DAYS THE PATIENT RETURNED TO THE HOSPITAL WITH SEVERE PAINS, AND IT WAS DETERMINED THAT THE CLIP HAS BECOME DETACHED FROM THE STOMACH WALL. THE SURGEON FOUND A 1 CM PERFORATION AND THE CLIP FLOATING. THE CLIP COULD BE REMOVED FROM THE STOMACH AND THE PERFORATION CLOSED BY SURGERY. AFTER FOUR DAYS THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITHOUT ANY FURTHER TREATMENT.

  Patient problems: Internal Organ Perforation

  MAUDE report 19246836 ↗
• DeathMar 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A GASTRODUODENAL FTRD WAS USED FOR REMOVAL A 1.5 CM NET LESION IN THE FIRST PART OF THE DUODENUM. WHILE TURNING THE HANDWHEEL OF THE CLIP RELEASE MECHANISM, THE PHYSICIAN ASSUMED THAT THE CLIP HAD BEEN SUCCESSFULLY APPLIED AND PERFORMED THE FULL THICKNESS RESECTION. HOWEVER, CLIP APPLICATION WAS VISUALLY NOT VERIFIED BEFOREHAND AS IT IS REQUIRED BY THE IFU OF THE PRODUCT AND USER TRAINING. THE RESULTING PERFORATION WAS SURGICALLY CLOSED BY LAPAROSCOPIC INTERVENTION. AFTER 10 - 15 DAYS THE MULTIMORBID PATIENT HAD CARDIOVASCULAR INSTABILITY AND DIES DESPITE ICU TREATMENT.

  Patient problems: Bowel Perforation; Internal Organ Perforation

  MAUDE report 18824043 ↗
• InjuryOct 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TWO DAYS AFTER A SUCCESSFUL FULL-THICKNESS BIOPSY IN THE STOMACH WITH THE GDFTRD, THE CLIP LOST ITS HOLD ON THE TISSUE, RESULTING IN A PERFORATION. THE PERFORATION HAD TO BE CLOSED SURGICALLY. THE PATIENT RECOVERED UNEVENTFUL FROM SURGERY WITHOUT ANY FURTHER TREATMENT.

  Patient problems: Internal Organ Perforation

  MAUDE report 18027682 ↗