DiLumen Endolumenal Interventional Platform, 130 cm DiLumen, 130 cmRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00865309000225), received between Jul 6, 2021 and Aug 1, 2022 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING A UNDERWATER ENDOLUMINAL PROCEDURE AND UPON REMOVAL OF THE ENDOSCOPE WITH DILUMEN ATTACHED, A 3CM PERFORATION APPROXIMATELY 30-35 CM FROM THE ANAL VERGE WAS NOTED REQUIRING SURGICAL INTERVENTION TO REPAIR. THE DOCTOR DID NOT ALLEGE A DEVICE MALFUNCTION..

  Patient problems: Bowel Perforation

  MAUDE report 15139785 ↗
• MalfunctionMay 8, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT HAD A TORTUOUS COLON THAT WAS DIFFICULT TO NAVIGATE. DURING NAVIGATION THE DOCTOR PUSHED THE DEVICE TOO DESPITE FEELING RESISTANCE. ONE PUSH ROD SEPARATED FROM THE FORE BALLOON SKIRT.. NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14332336 ↗
• InjuryJan 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ENDOLUMINAL PROCEDURE A PERFORATION OF THE SIGMOID COLON OCCURRED REQUIRING SURGICAL INTERVENTION TO REPAIR. THE CUSTOMER DID NOT ALLEGE THAT THE DEVICE MALFUNCTIONED.

  Patient problems: Bowel Perforation

  MAUDE report 13154428 ↗
• InjuryDec 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS EVENT OCCURED IN (B)(6) 2021 BUT WAS NOT REPORTED TO LUMENDI UNTIL 11/22/2021. WHEN THE NEW SALES MANAGER VISITED THE ACCOUNT, HE WAS INFORMED A PATIENT WAS READMITTED IN LATE (B)(6) 2021 WITH ABDOMINAL PAIN SHORTLY AFTER ESD WITH THE DEVICE AND WAS SUBSEQUENTLY FOUND TO HAVE A PERFORATION ON THE LEFT SIDE OF THE COLON THAT REQUIRED SURGICAL INTERVENTION. THE USER REPORTED AT THE TIME OF THE ENDOSCOPIC INTERVENTION HE HAD DIFFICULTY NAVIGATING THE ENDOSCOPE THROUGH THE SIGMOID COLON AS THE PATIENT HAD PREVIOUS PELVIC SURGERY.

  Patient problems: Bowel Perforation

  MAUDE report 13046353 ↗
• MalfunctionOct 11, 2021Mechanical Problem; Mechanical Problem

  DURING POLYPECTOMY, DOCTOR NOTICED MIGRATION OF DEVICE FORE BALLOON AND THEN NOTICED THAT THE FORE BALLOON WAS COMPLETELY SEPARATED FROM DEVICE WITH BOTH PUSH RODS BROKEN. DOCTOR REMOVED DILUMEN DEVICE AND THEN SEPARATELY WENT BACK IN WITH A SNARE TO REMOVE FB AND PUSH ROD SEGMENTS. POST-PROCEDURE, X RAY WAS DONE WHICH REVEALED NO PERFORATION OF THE COLON.

  Patient problems: Insufficient Information

  MAUDE report 12605859 ↗
• MalfunctionSep 8, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT HAD A TORTUOUS COLON THAT WAS DIFFICULT TO NAVIGATE. THE ENDOSCOPE WAS POSITIONED SLIGHTLY FORWARD OF THE FORE BALLOON. THE FORE BALLOON WAS IN THE FULLY RETRACTED POSITION. UPON PULLING THE ENDOSCOPE BACKWARD THE DOCTOR NOTED THE DAMAGE TO THE PUSH RODS. ONE PUSH ROD SEPARATED FROM THE SADDLE TIP AND THE OTHER PUSH ROD BROKE AT THE FORE BALLOON SKIRT. NO ADVERSE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 12442580 ↗
• MalfunctionAug 24, 2021Mechanical Problem; Mechanical Problem

  PATIENT HAD A 3 CM LESION IN THE ASCENDING COLON. PATIENT HAD A VERY TORTUOUS ANATOMY AND THE DOCTOR HAD DIFFICULTY NAVIGATING TO THE LESION SITE. HE WAS ABLE TO SEE THE LESION IN THE ENDOSCOPIC VIEW.. WHEN HE HAD TROUBLE GOING ANY FURTHER, HE STARTED TO MANIPULATE THE DILUMEN FORE BALLOON BY TRYING TO EXTEND IT PAST THE LESION. HE WAS UNABLE TO GET PAST THE LESION AND PULLED THE DEVICE OUT AND THAT IS WHEN WE SAW THE PUSH ROD ON THE LEFT BECAME SEPARATED. THE CASE WAS FINISHED WITH ONLY THE ADULT PENTAX COLONOSCOPE AND THE PATIENT WAS DISCHARGED THAT SAME DAY. NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12363020 ↗
• InjuryJul 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PERFORATION OF RECTO-SIGMOID COLON. PATIENT- (B)(6)-YEAR-OLD, FEMALE WITH A TORTUOUS COLON AND A FIXED SIGMOID COLON DUE TO PREVIOUS OOPHORECTOMY AND APPENDECTOMY. THE ENDOSCOPE AND DILUMEN ENTERED THE ANUS AND THE DOCTOR PROCEEDED TO INTRODUCE THE ENDOSCOPE/DILUMEN THROUGH THE RECTUM AND UP INTO THE SIGMOID. APPROX. 8 MINUTES LATER BLEEDING WOULD BE SEEN AT THE ANUS. AFTER REMOVING BOTH DILUMEN AND THE SCOPE, THE SCOPE WAS REINSERTED WITHOUT DILUMEN, AND A PERFORATION (APPROXIMATELY 4 CM) WAS DISCOVERED IN THE AREA OF THE RECTO-SIGMOID COLON. THE PERFORATION WAS CLOSED ENDOSCOPICALLY AND CONFIRMED UNDER FLUOROSCOPY. THERE WAS NO FURTHER SEQUELAE FROM THE INCIDENT. THE ATTENDING DOCTOR INDICATED THAT IT WAS LIKELY THAT AGGRESSIVE NAVIGATION OF THE ENDOSCOPE/DEVICE IN A NARROW AND FIXED SIGMOID PATIENT'S ANATOMY CAUSED THE PERFORATION AND WAS NOT SPECIFICALLY DEVICE RELATED.

  Patient problems: Bowel Perforation

  MAUDE report 12125374 ↗