DISPOSABLE DISTAL ATTACHMENT D-201-11804 (REF N3529140)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04953170453854), received between Sep 25, 2023 and Jul 15, 2025 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2025Device Reprocessing Problem; Device Reprocessing Problem

  NO ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22506393 ↗
• InjuryOct 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "EFFICACY OF A NOVEL TRACTION METHOD: OUTSIDE-LESION CLIP-THREAD METHOD FOR GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION OF LESIONS OF THE GREATER CURVATURE OF THE UPPER/MIDDLE STOMACH (WITH VIDEO)." ABSTRACT BACKGROUND GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) FOR LESIONS LOCATED ON THE GREATER CURVATURE OF THE UPPER AND MIDDLE (U/M) THIRD OF THE STOMACH REMAINS CHALLENGING, EVEN FOR EXPERIENCED ENDOSCOPISTS. ACCORDINGLY, WE HAVE DEVELOPED A NOVEL TRACTION TECHNIQUE, TERMED THE OUTSIDE-LESION CLIP-THREAD METHOD (O-CTM). IN THIS METHOD, A CLIP THREAD IS ATTACHED TO THE HEALTHY MUCOSA OUTSIDE THE CIRCUMFERENTIAL INCISION LINE, AND TRACTION IS APPLIED TO BRING THE SCOPE AND LESION INTOPROXIMITY FOR ESD. HERE, WE ASSESSED THE EFFICACY OF ESD USING THE O-CTM COMPARED TO ESD WITHOUT THE O-CTM. METHODS WE RETROSPECTIVELY REVIEWED DATA FROM 63 CONSECUTIVE PATIENTS WHO UNDERWENT GASTRIC ESD FOR 63 LESIONS LOCATED ON THE GREATER CURVATURE OF THE U/M THIRD OF THE STOMACH BETWEEN SEPTEMBER 2015 AND APRIL 2024. THE PRIMARY OUTCOME WAS THE OPERATION TIME, AND SECONDARY OUTCOMES WERE RESECTION SPEED, EN BLOC RESECTION, R0 RESECTION AND COMPLICATI

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 20499099 ↗
• InjuryOct 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "EFFICACY OF A NOVEL TRACTION METHOD: OUTSIDE-LESION CLIP-THREAD METHOD FOR GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION OF LESIONS OF THE GREATER CURVATURE OF THE UPPER/MIDDLE STOMACH (WITH VIDEO)." ABSTRACT BACKGROUND GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) FOR LESIONS LOCATED ON THE GREATER CURVATURE OF THE UPPER AND MIDDLE (U/M) THIRD OF THE STOMACH REMAINS CHALLENGING, EVEN FOR EXPERIENCED ENDOSCOPISTS. ACCORDINGLY, WE HAVE DEVELOPED A NOVEL TRACTION TECHNIQUE, TERMED THE OUTSIDE-LESION CLIP-THREAD METHOD (O-CTM). IN THIS METHOD, A CLIP THREAD IS ATTACHED TO THE HEALTHY MUCOSA OUTSIDE THE CIRCUMFERENTIAL INCISION LINE, AND TRACTION IS APPLIED TO BRING THE SCOPE AND LESION INTOPROXIMITY FOR ESD. HERE, WE ASSESSED THE EFFICACY OF ESD USING THE O-CTM COMPARED TO ESD WITHOUT THE O-CTM. METHODS WE RETROSPECTIVELY REVIEWED DATA FROM 63 CONSECUTIVE PATIENTS WHO UNDERWENT GASTRIC ESD FOR 63 LESIONS LOCATED ON THE GREATER CURVATURE OF THE U/M THIRD OF THE STOMACH BETWEEN SEPTEMBER 2015 AND APRIL 2024. THE PRIMARY OUTCOME WAS THE OPERATION TIME, AND SECONDARY OUTCOMES WERE RESECTION SPEED, EN BLOC RESECTION, R0 RESECTION AND COMPLICATI

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 20495841 ↗
• InjuryAug 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ALTHOUGH ADDITIONAL INFORMATION WAS REQUESTED, THE AUTHOR REPORTED THAT FURTHER EVENT DETAILS ARE UNKNOWN.

  Patient problems: Bacterial Infection; Chest Pain; Fever; Hemorrhage/Blood Loss/Bleeding; High White Blood Cell Count

  MAUDE report 20065599 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "SUBLINGUAL NITROGLYCERINE SPRAY FACILITATES EFFICIENT SUBMUCOSAL TUNNELING DURING PER ORAL ENDOSCOPIC MYOTOMY-A NONRANDOMIZED TRIAL." LITERATURE SUMMARY THIS STUDY DESCRIBES A NEW METHOD OF USING SUBLINGUAL NITROGLYCERINE SPRAY DURING SUBMUCOSAL TUNNELING TO FACILITATE THE PROCEDURE. THIS STUDY INCLUDES A COHORT OF 50 PATIENTS WHO WERE DIAGNOSED WITH ACHALASIA CARDIA ON HIGH-RESOLUTION ESOPHAGEAL MANOMETRY. ALL THE PROCEDURES WERE TECHNICALLY FEASIBLE AND SUCCESSFUL WITHOUT ANY MAJOR COMPLICATIONS. ECKHARDT¿S SCORES OF ALL PATIENTS NORMALIZED AFTER THE PROCEDURE. THE MEAN SUBMUCOSAL TUNNELING TIME AND MEAN TIME ACROSS GEJ WERE 36.8±7.9, 14.2±2.9 IN INTERVENTION GROUP (SUBLINGUAL NITROGLYCERINE), AND 50.2±8.9 AND 23.0±3.6 MINUTES IN NONINTERVENTION GROUP, RESPECTIVELY. TIME FOR EACH PROCEDURE WAS SIGNIFICANTLY LESS (P < 0.05) IN PATIENTS WHO WERE GIVEN SUBLINGUAL NITROGLYCERINE. ADVERSE EVENTS: ALL THE PROCEDURES WERE TECHNICALLY SUCCESSFUL WITHOUT ANY LONG-TERM COMPLICATIONS. THERE WAS MINIMAL MUCOSAL INJURY (TYPE 1) IN THREE PATIENTS (INTERVENTION GROUP 1 AND NONINTERVENTION 2) THAT WERE LEFT ALONE WITHOUT ANY CONSEQUENCE. TWO PATI

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding; Pleural Effusion

  MAUDE report 20053297 ↗
• InjuryJun 10, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THE DISPOSABLE DISTAL ATTACHMENT BROKE OFF OF THE GASTROINTESTINAL VIDEOSCOPE AND FELL INTO THE STOMACH DURING A THERAPEUTIC ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE. IT WAS UNKNOWN WHETHER IT WAS A PART OF THE DISPOSABLE DISTAL ATTACHMENT OR THE MAIN BODY THAT FELL INTO THE PATIENT. THE DEVICE WAS RETRIEVED ENDOSCOPICALLY. THERE WAS NO SIGNIFICANT EXTENSION OF THE PROCEDURE, AND IT WAS COMPLETED WITH ANOTHER PRODUCT OF THE SAME MODEL NUMBER. IT WAS NOTED THAT THE ENDOSCOPE THE DEVICE WAS ATTACHED TO WAS INSERTED AND REMOVED FROM THE BODY SEVERAL TIMES, SO IT MAY HAVE BEEN SUBJECTED TO STRESS. THERE WAS NO REPORTED PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19499947 ↗
• InjuryMay 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED, THE DISPOSABLE DISTAL ATTACHMENT (CAP) FELL OFF FROM THE GASTROINTESTINAL VIDEOSCOPE AND INTO THE PATIENT'S STOMACH IN THE MIDDLE OF A THERAPEUTIC ESOPHAGOGASTRODUODENOSCOPY WITH FOOD BOLUS DISIMPACTION AND WAS RETRIEVED BY THE PHYSICIAN. THE PROCEDURE AND PATIENT'S ANESTHESIA WERE PROLONGED FOR ABOUT 30 MINUTES AND WAS COMPLETED WITH A DIFFERENT SCOPE AND CAP. THE PATIENT WAS INTUBATED PRIOR TO THE PROCEDURE DUE TO ASPIRATION RISK AND WAS EXTUBATED THE NEXT DAY. REPORTEDLY, THE PLAN WOULD MOST LIKELY HAVE BEEN THE SAME EVEN IF THE CAP HAD NOT FALLEN OFF DUE TO THE LARGE AMOUNT OF RETAINED FOOD. THE CUSTOMER CONFIRMED THAT THE CONDITION OF THE PATIENT AND OUTCOME OF THE PROCEDURE WAS NOT IMPACTED. BOTH DEVICES WERE INSPECTED PRIOR TO USE AND THE STAFF HAD MADE SURE THAT THE SCOPE WAS COMPATIBLE WITH THE CAP. THE PATIENT WAS DISCHARGED TO HOME WITHOUT ANY FURTHER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19249349 ↗
• InjuryMay 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED, THE DISPOSABLE DISTAL ATTACHMENT (CAP) FELL OFF FROM THE GASTROINTESTINAL VIDEOSCOPE AND INTO THE PATIENT'S STOMACH IN THE MIDDLE OF A THERAPEUTIC ESOPHAGOGASTRODUODENOSCOPY WITH FOOD BOLUS DISIMPACTION AND WAS RETRIEVED BY THE PHYSICIAN. THE PROCEDURE AND PATIENT'S ANESTHESIA WERE PROLONGED FOR ABOUT 30 MINUTES AND WAS COMPLETED WITH A DIFFERENT SCOPE AND CAP. THE PATIENT WAS INTUBATED PRIOR TO THE PROCEDURE DUE TO ASPIRATION RISK AND WAS EXTUBATED THE NEXT DAY. REPORTEDLY, THE PLAN WOULD MOST LIKELY HAVE BEEN THE SAME EVEN IF THE CAP HAD NOT FALLEN OFF DUE TO THE LARGE AMOUNT OF RETAINED FOOD. THE CUSTOMER CONFIRMED THAT THE CONDITION OF THE PATIENT AND OUTCOME OF THE PROCEDURE WAS NOT IMPACTED. BOTH DEVICES WERE INSPECTED PRIOR TO USE AND THE STAFF HAD MADE SURE THAT THE SCOPE WAS COMPATIBLE WITH THE CAP. THE PATIENT WAS DISCHARGED TO HOME WITHOUT ANY FURTHER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19249279 ↗
• InjuryApr 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION OBTAINED: IT WAS REPORTED THAT THERE HAVE BEEN NO MALFUNCTIONS IN THE MOST RECENT USE, AND THE DOCTOR ON THE SCENE BELIEVES THAT THERE WAS SOMETHING WRONG WITH THE WAY THE SCOPE WAS USED. (FOR EXAMPLE, THE ENDOSCOPIST SAID THAT THE TAPE WAS NOT WRAPPED PROPERLY WHEN ATTACHING THE SCOPE.) FURTHERMORE, OLYMPUS WAS ABLE TO CONFIRM THAT THE DISTAL ATTACHMENT CAP WAS FIXED WITH MEDICAL TAPE. IT SEEMS THAT IN THE PAST IT WAS NOT FIXED, BUT IT HAS BEEN FIXED RECENTLY. ADDITIONALLY, IT WAS REPORTED THAT WIPING OFF AFTER USING LUBRICANTS ETC. IS PROBABLY NOT A PROBLEM, BUT SOME ENDOSCOPISTS HAVE COMMENTED THAT THE TAPE IS NOT BEING APPLIED PROPERLY (E.G., THE TAPE IS NOT STICKING PROPERLY).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19188390 ↗
• InjuryFeb 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "USEFULNESS OF THE S-O CLIP FOR DUODENAL ENDOSCOPIC SUBMUCOSAL DISSECTION: A PROPENSITY SCORE-MATCHED STUDY." THIS RETROSPECTIVE STUDY EVALUATED THE EFFICACY AND SAFETY OF DUODENAL ESD USING AN S-O CLIP FOR SNADETS. THE RETROSPECTIVE STUDY WAS PATIENTS WHO UNDERWENT ESD FOR SNADETS BETWEEN JANUARY 2011 AND DECEMBER 2021. PROPENSITY SCORE MATCHING ANALYSIS WAS USED TO COMPARE PATIENTS WHO UNDERWENT DUODENAL ESD WITH THE S-O CLIP (S-O GROUP) AND THOSE WHO UNDERWENT CONVENTIONAL ESD (CONTROL GROUP). SIXTY PATIENTS WITH SNADETS WHO WERE TREATED WITH ESD WERE ENROLLED. AFTER PROPENSITY SCORE MATCHING, 16 PAIRS WERE CREATED: 43 AND 17 IN THE S-O AND CONTROL GROUPS, RESPECTIVELY. ALL ESD PROCEDURES WERE PERFORMED USING A SINGLE-CHANNEL ENDOSCOPE (GIF-H260J) WITH A TRANSPARENT HOOD (D-201-11804) AND HOOK KNIFE (KD-625LR). S-O GROUP: 43 PATIENTS DELAYED BLEEDING: 2 PATIENTS CONTROL GROUP: 17 PATIENTS INTRAOPERATIVE PERFORATION: 4 PATIENTS DELAYED PERFORATION: 1 PATIENT IN CASE OF DELAYED COMPLICATIONS, COMPUTED TOMOGRAPHY AND BLOOD TESTS WERE PERFORMED. DELAYED BLEEDING TREATED WITH ENDOSCOPIC HEMOSTASIS AFTER ESD. MOST OF THE CASES OF INTRAO

  Patient problems: Abscess; Bowel Perforation; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18636449 ↗
• InjurySep 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS RECEIVED FURTHER INFORMATION INDICATING THAT THE AUTHOR HAS CONFIRMED THAT THE ADVERSE EVENTS DESCRIBED IN THE LITERATURE WERE NOT FROM THE OLYMPUS DEVICES AND THAT THERE WAS NO MALFUNCTION OF ANY KIND WITH THE OLYMPUS DEVICES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17807672 ↗