DISPOSABLE DISTAL ATTACHMENT D-201-10704Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 04953170278266), received between Feb 28, 2019 and Jul 11, 2025 — classified as 10 injuries, 5 malfunctions.

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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2025Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT SIX (6) DISPOSABLE DISTAL ATTACHMENTS WERE BEING REPROCESSED AND USED. THE ISSUE WAS OBSERVED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM. THIS IS REPORT 1 OF 6.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22478281 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "EFFICACY AND SAFETY OF MC-003 SOLUTION FOR ENDOSCOPIC MUCOSAL OR SUBMUCOSAL RESECTION: A PROSPECTIVE, MULTICENTER, RANDOMIZED, TRIPLE-BLINDED, PARALLEL-GROUP, PHASE III STUDY." BACKGROUND AND AIMS: THE SAFETY AND EFFICACY OF SOLUTIONS FOR SUBMUCOSAL INJECTION ARE CRITICAL FOR ENDOSCOPIC RESECTION OF GASTRIC ADENOMAS OR EARLY GASTRIC CANCERS. ALTHOUGH SEVERAL INJECTABLE SOLUTIONS HAVE BEEN INTRODUCED FOR ENDOSCOPIC RESECTION, THEY HAVE SOME LIMITATIONS. WE AIMED TO COMPARE THE EFFICACY OF THE NEW SODIUM ALGINATE¿BASED SOLUTION MC-003 WITH THAT OF NORMAL SALINE (NS; 0.9% SODIUM CHLORIDE). METHODS: IN THIS RANDOMIZED, TRIPLE-BLIND STUDY, 70 PATIENTS WERE INITIALLY ENROLLED FOR EMR OR ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD). THE MAIN OUTCOMES INCLUDED THE NEED FOR ADDITIONAL INJECTIONS, COMPLETION OF EN BLOC RESECTION, AND OCCURRENCE OF ADVERSE EVENTS. RESULTS: EACH GROUP ULTIMATELY INCLUDED 34 PATIENTS. COMPLETE EN BLOC RESECTIONS WERE ACHIEVED IN ALL PATIENTS (P Z 1.000). THE MC-003 GROUP HAD MORE PERI-NEOPLASM TISSUE FIBROSIS (P Z .056) AND NEEDED FEWER ADDITIONAL INJECTIONS FOR LESIONS >15 MM (P Z .037), LOCATED IN THE DISTAL PORTION

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 20043910 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "EFFICACY AND SAFETY OF MC-003 SOLUTION FOR ENDOSCOPIC MUCOSAL OR SUBMUCOSAL RESECTION: A PROSPECTIVE, MULTICENTER, RANDOMIZED, TRIPLE-BLINDED, PARALLEL-GROUP, PHASE III STUDY." BACKGROUND AND AIMS: THE SAFETY AND EFFICACY OF SOLUTIONS FOR SUBMUCOSAL INJECTION ARE CRITICAL FOR ENDOSCOPIC RESECTION OF GASTRIC ADENOMAS OR EARLY GASTRIC CANCERS. ALTHOUGH SEVERAL INJECTABLE SOLUTIONS HAVE BEEN INTRODUCED FOR ENDOSCOPIC RESECTION, THEY HAVE SOME LIMITATIONS. WE AIMED TO COMPARE THE EFFICACY OF THE NEW SODIUM ALGINATE¿BASED SOLUTION MC-003 WITH THAT OF NORMAL SALINE (NS; 0.9% SODIUM CHLORIDE). METHODS: IN THIS RANDOMIZED, TRIPLE-BLIND STUDY, 70 PATIENTS WERE INITIALLY ENROLLED FOR EMR OR ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD). THE MAIN OUTCOMES INCLUDED THE NEED FOR ADDITIONAL INJECTIONS, COMPLETION OF EN BLOC RESECTION, AND OCCURRENCE OF ADVERSE EVENTS. RESULTS: EACH GROUP ULTIMATELY INCLUDED 34 PATIENTS. COMPLETE EN BLOC RESECTIONS WERE ACHIEVED IN ALL PATIENTS (P Z 1.000). THE MC-003 GROUP HAD MORE PERI-NEOPLASM TISSUE FIBROSIS (P Z .056) AND NEEDED FEWER ADDITIONAL INJECTIONS FOR LESIONS >15 MM (P Z .037), LOCATED IN THE DISTAL PORTION

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 20042404 ↗
• InjuryJul 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE ARTICLE "EFFICACY OF TEXTURE AND COLOR ENHANCEMENT IMAGING FOR SHORT-TYPE SINGLE-BALLOON ENTEROSCOPY-ASSISTED BILIARY CANNULATION IN PATIENTS WITH ROUX-EN-Y GASTRECTOMY: MULTICENTER STUDY (WITH VIDEO)". THIS MULTICENTER STUDY EVALUATED THE EFFICACY OF SHORT-TYPE SINGLE-BALLOON ENTEROSCOPY (SBE)-ASSISTED BILIARY CANNULATION USING A NEW-GENERATION IMAGE-ENHANCED ENDOSCOPY PROCESSING SYSTEM EQUIPPED WITH TXI IN PATIENTS WHO UNDERWENT ROUX-EN-Y GASTRECTOMY. PATIENTS WITH ROUX-EN-Y GASTRECTOMY WITH A NATIVE PAPILLA, AND UNDERWENT SHORT SBE-ASSISTED BILIARY CANNULATION DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY RELATED PROCEDURES BETWEEN JANUARY 2019 AND APRIL 2023 WERE RETROSPECTIVELY REVIEWED. ADVERSE EVENTS WERE DEFINED AND GRADED ACCORDING TO THE AMERICAN SOCIETY FOR GASTROINTESTINAL ENDOSCOPY SEVERITY GRADING SYSTEM. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS PANCREATITIS: MILD (6). CHOLANGITIS: MILD (2). INTESTINAL PERFORATION: MODERATE (3) . ALL PATIENTS WHO EXPERIENCED ADVERSE EVENTS RECOVERED AFTER CONSERVATIVE THERAPY.

  Patient problems: Bowel Perforation; Cholangitis; Pancreatitis

  MAUDE report 19652690 ↗
• MalfunctionApr 26, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A USER FACILITY REPORTED THAT DURING AN EMERGENCY ENDOSCOPY, THE DISPOSABLE DISTAL ATTACHMENT FELL OFF THE SCOPE AND COULD NOT BE RECOVERED FROM THE STOMACH. THE RECOVERY WAS ABANDONED BY THE SURGEON AS THERE WAS SEVERE RESIDUE. IT WAS NOTED THAT THE SCOPE AND DISTAL ATTACHMENT WERE FIXED WITH MEDICAL TAPE. ADDITIONAL INFORMATION REGARDING THE OUTCOME WAS REQUESTED BUT NOT RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16815069 ↗
• InjuryFeb 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED: THE EVENTS DESCRIBED IN THIS ARTICLE WERE NOT CAUSED BY AN OLYMPUS DEVICE. IN ADDITION, THERE WERE NO DEVICE MALFUNCTIONS.

  Patient problems: Pancreatitis; Perforation; Unspecified Hepatic or Biliary Problem

  MAUDE report 16440660 ↗
• InjuryFeb 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "COMPETENCE DEVELOPMENT OF TRAINEES PERFORMING SHORT-TYPE SINGLE-BALLOON ENTEROSCOPY-ASSISTED ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY IN PATIENTS WITH SURGICALLY ALTERED ANATOMY.¿ OBJECTIVES: THIS STUDY AIMED TO EVALUATE THE TRAINEES' PRACTICE AND LEARNING CURVE IN SHORT-TYPE SINGLE-BALLOON ENTEROSCOPY (SHORT SBE)-ASSISTED ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) FOR PATIENTS WITH SURGICALLY ALTERED ANATOMY (SAA) AND DETERMINE HOW TO TRAIN THESE TRAINEES. METHODS: THE DATA OF SHORT SBE-ASSISTED ERCP PROCEDURES BETWEEN SEPTEMBER 2011 AND JUNE 2021 WERE ANALYZED. RESULTS : THREE TRAINEES AND 180 CASES WERE INCLUDED IN THE ANALYSIS. EACH TRAINEE PERFORMED 60 CASES BETWEEN APRIL 2016 AND JUNE 2021. THE TRAINEES' COMPLETION RATE WAS 73.9% (95% CONFIDENCE INTERVAL [CI], 66.8-80.1%). ADVERSE EVENTS OCCURRED IN 5.0% OF CASES (95% CI, 2.3-9.3%). THE TRAINEE WHO EXPERIENCED COLONOSCOPY AND ERCP THE MOST ACHIEVED BETTER OUTCOMES OF ENTEROSCOPY SUCCESS (REACHING THE TARGET SITE) AND TRAINEE'S COMPLETION RATES THAN THOSE OF THE OTHERS (P = .03 AND .02, RESPECTIVELY). THE LEARNING CURVE FOR TRAINEE'S COMPLETION

  Patient problems: Pancreatitis; Perforation; Unspecified Hepatic or Biliary Problem

  MAUDE report 16439807 ↗
• InjuryAug 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED ¿MARGIN MARKING BEFORE COLORECTAL ENDOSCOPIC MUCOSAL RESECTION AND ITS IMPACT ON NEOPLASIA RECURRENCE,¿ TWO PATIENTS EXPERIENCED DELAYED BLEEDING AFTER PROCEDURES USING A COLONOSCOPE AND A DISTAL ATTACHMENT CAP. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE SCOPE USED IN THE PROCEDURES. CASE WITH PATIENT IDENTIFIER (B)(4) REPORTS THE DISTAL ATTACHMENT CAP USED IN THE PROCEDURES. BACKGROUND AND AIMS: ABLATION OF RESECTION MARGINS AFTER EMR OF LARGE NONPEDUNCULATED COLORECTAL POLYPS DECREASES RECURRENCE. MARGIN MARKING BEFORE EMR (EMR-MM) MAY REPRESENT AN ALTERNATIVE METHOD TO ACHIEVE A HEALTHY RESECTION MARGIN. WE AIMED TO DETERMINE THE EFFICACY OF EMR-MM IN REDUCING NEOPLASIA RECURRENCE. METHODS: WE CONDUCTED A SINGLE-CENTER HISTORICAL CONTROL STUDY OF EMR CASES (EMR-MM VS CONVENTIONAL EMR) FOR NONPEDUNCULATED POLYPS >20 MM BETWEEN 2016 AND 2021. FOR EMR-MM, CAUTERY MARKS WERE PLACED ALONG THE LATERAL MARGINS OF THE POLYP WITH THE SNARE TIP. EMR WAS THEN PERFORMED TO INCLUDE RESECTION OF THE HEALTHY MUCOSA CONTAINING THE MARKS. WE COMPARED RECURRENCE AT SURVEILLANCE COLONOSCOPY AFTER EMR-MM VERSUS HISTORICAL CONTROL SUBJECTS. MULTIVARIABLE

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15257466 ↗
• InjuryAug 19, 2022Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED ¿MARGIN MARKING BEFORE COLORECTAL ENDOSCOPIC MUCOSAL RESECTION AND ITS IMPACT ON NEOPLASIA RECURRENCE,¿ TWO PATIENTS EXPERIENCED DELAYED BLEEDING AFTER PROCEDURES USING A COLONOSCOPE AND A DISTAL ATTACHMENT CAP. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE SCOPE USED IN THE PROCEDURES. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE DISTAL ATTACHMENT CAP USED IN THE PROCEDURES. BACKGROUND AND AIMS: ABLATION OF RESECTION MARGINS AFTER EMR OF LARGE NONPEDUNCULATED COLORECTAL POLYPS DECREASES RECURRENCE. MARGIN MARKING BEFORE EMR (EMR-MM) MAY REPRESENT AN ALTERNATIVE METHOD TO ACHIEVE A HEALTHY RESECTION MARGIN. WE AIMED TO DETERMINE THE EFFICACY OF EMR-MM IN REDUCING NEOPLASIA RECURRENCE. METHODS: WE CONDUCTED A SINGLE-CENTER HISTORICAL CONTROL STUDY OF EMR CASES (EMR-MM VS CONVENTIONAL EMR) FOR NONPEDUNCULATED POLYPS >20 MM BETWEEN 2016 AND 2021. FOR EMR-MM, CAUTERY MARKS WERE PLACED ALONG THE LATERAL MARGINS OF THE POLYP WITH THE SNARE TIP. EMR WAS THEN PERFORMED TO INCLUDE RESECTION OF THE HEALTHY MUCOSA CONTAINING THE MARKS. WE COMPARED RECURRENCE AT SURVEILLANCE COLONOSCOPY AFTER EMR-MM VERSUS HISTORICAL CONTROL SUBJECTS. MULTIVARIABLE

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15257370 ↗
• InjuryJun 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED ¿IMPACT OF SCOPE EXCHANGE FROM A LONG SINGLE BALLOON ENTEROSCOPE TO A GASTROSCOPE DURING ENTEROSCOPY-ASSISTED ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY IN PATIENTS WITH SURGICALLY ALTERED ANATOMY,¿ PATIENTS EXPERIENCED ADVERSE EFFECTS DURING OR AFTER PROCEDURES USING OLYMPUS DEVICES. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS GIF-CQ260. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS SIF-Q260. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS ST-SB1. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS OBCU. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS D-201-10704. BACKGROUND/AIMS: ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) IN PATIENTS WITH SURGICALLY ALTERED ANATOMY (SAA) IS CHALLENGING TO GASTROINTESTINAL ENDOSCOPISTS. THE AIM OF THIS STUDY WAS TO EVALUATE THE IMPACT OF SCOPE EXCHANGE FROM A LONG SINGLE BALLOON ENTEROSCOPE (SBE) TO A GASTROSCOPE DURING SBE-ASSISTED ERCP (SBE-ERCP) IN PATIENTS WITH SAA. METHODS: PATIENTS WHO UNDERWENT SBE-ERCP BETWEEN FEBRUARY 2019 AND OCTOBER 2020 WERE RETROSPECTIVELY IDENTIFIED. INTUBATION SUCCESS, SCOPE EXCHANGE SUCCESS, CANNULATION SUCCESS, AND THERAPEUTIC SUCCESS WERE ANALYZED ALONG WITH COMPLICATIONS. RES

  Patient problems: Perforation

  MAUDE report 14760274 ↗
• MalfunctionMay 14, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS, THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE DISPOSABLE DISTAL ATTACHMENT CAP FELL OFF INSIDE THE BODY OF THE PATIENT. IT WAS REPORTED THAT THE CAP WAS ATTACHED TO THE SCOPE AND THE HOOD ORIGINALLY ENTERED THE OPERATION PART FOR COUPLE OF MILLIMETERS BUT WAS IN A STATE OF BEING PUSHED BACK. THE ATTACHMENT WAS IMMEDIATELY COLLECTED, AND THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14403658 ↗
• InjuryApr 22, 2022Separation Problem; Separation Problem

  OLYMPUS WAS INFORMED OF THE CUSTOMER'S EVENT VIA MW5107777. THE CUSTOMER REPORTED, DURING AN UNKNOWN PROCEDURE, THE DISTAL ATTACHMENT ATTACHED TO THE ENDOSCOPE WAS SEEN IN THE PATIENT'S STOMACH. IT WAS RETRIEVED WITH A ROTH NET. THE DISTAL ATTACHMENT WAS INSPECTED PRIOR TO USE AND NO ISSUES WERE FOUND. THE DISTAL ATTACHMENT WAS INSPECTED AFTER REMOVAL FROM THE PATIENT AND FOUND TO BE CUT IN HALF. A REQUEST FOR ADDITIONAL INFORMATION IS IN PROGRESS. UPDATE: THIS EVENT INCLUDES 2 COMPLAINTS: (B)(6) - DISTAL CAP; (B)(6) - UNKNOWN EGD SCOPE. THIS IS REPORT 1 OF 2 FOR (B)(6) - DISTAL CAP.

  Patient problems: Foreign Body In Patient

  MAUDE report 14189315 ↗
• InjuryApr 22, 2022Material Split, Cut or Torn

  OLYMPUS WAS INFORMED OF THE CUSTOMER'S EVENT VIA MW5107777. THE CUSTOMER REPORTED, DURING AN UNKNOWN PROCEDURE, THE DISTAL ATTACHMENT ATTACHED TO THE ENDOSCOPE WAS SEEN IN THE PATIENT'S STOMACH. IT WAS RETRIEVED WITH A ROTH NET. THE DISTAL ATTACHMENT WAS INSPECTED PRIOR TO USE AND NO ISSUES WERE FOUND. THE DISTAL ATTACHMENT WAS INSPECTED AFTER REMOVAL FROM THE PATIENT AND FOUND TO BE CUT IN HALF. A REQUEST FOR ADDITIONAL INFORMATION IS IN PROGRESS. UPDATE: THIS EVENT INCLUDES 2 COMPLAINTS: (B)(6)- DISTAL CAP. (B)(6)- UNKNOWN EGD SCOPE/GM-418500, (B)(6) 2022.

  Patient problems: Foreign Body In Patient

  MAUDE report 14188968 ↗
• MalfunctionFeb 28, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, THE DEVICE (DISTAL END ATTACHMENT) BECAME DETACHED FROM DISTAL END OF THE SCOPE AND FELL INTO THE PATIENT. THE DOCTOR RETRIEVED THE DEVICE FROM THE PATIENT SUCCESSFULLY AND THE INTENDED PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED FROM THE USER FACILITY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8380282 ↗
• MalfunctionFeb 28, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, THE DEVICE (DISTAL END ATTACHMENT) BECAME DETACHED FROM DISTAL END OF THE SCOPE (GIF-H190) AND FELL INTO THE PATIENT¿S OROPHARYNX. THE DOCTOR RETRIEVED THE DEVICE FROM THE PATIENT SUCCESSFULLY AND THE INTENDED PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED FROM THE USER FACILITY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8377166 ↗