DISPOSABLE BENDING CANNULA PR-233QRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04953170044243), received between Feb 25, 2022 and Jan 8, 2026 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "REDUCED RECURRENCE RATE WITH A TARGETED APPROACH IN UNCOMPLICATED APPENDICITIS TREATED WITH ENDOSCOPIC DIRECT VS RETROGRADE THERAPY." ABSTRACT: BACKGROUND: ENDOSCOPIC RETROGRADE APPENDICITIS THERAPY (ERAT) OFFERS AN APPENDIX-PRESERVING APPROACH; HOWEVER, VISUAL AND SPECIFICITY CHALLENGES PERSIST. CONVERSELY, ENDOSCOPIC DIRECT APPENDICITIS THERAPY (EDAT) PROVIDES DIRECT VISUAL OBSERVATION WITH DIAGNOSTIC AND THERAPEUTIC CAPABILITIES. AIM: TO ASSESS THE EFFICACY AND FEASIBILITY OF EDAT AND COMPARE THEM WITH THOSE OF ERAT IN UNCOMPLICATED APPENDICITIS. METHODS: IN THIS RETROSPECTIVE COHORT STUDY, PATIENTS DIAGNOSED WITH UNCOMPLICATED APPENDICITIS AND TREATED WITH ERAT OR EDAT BETWEEN JANUARY 2021 AND NOVEMBER 2024 WERE REVIEWED. THE PRIMARY OUTCOME WAS INTERVENTION SUCCESS. SECONDARY OUTCOMES WERE GUIDEWIRE USE, STENT PLACEMENT, HOSPITALIZATION DURATION, RECURRENCE, AND ENDOSCOPIC DIRECT-VIEW FEATURES. OUTCOMES WERE COMPARED BETWEEN GROUPS VIA APPROPRIATE STATISTICAL TESTS. RESULTS: OF 170 PATIENTS, 136 UNDERWENT EDAT AND 34 ERAT. EDAT SHOWED HIGHER INTERVENTION SUCCESS THAN ERAT (99.3% VS 82.4%, P < 0.001), WITH LESS

  Patient problems: Bowel Perforation

  MAUDE report 24003615 ↗
• InjuryJun 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "A MULTICENTER STUDY OF SHORT SBE-ASSISTED BILIARY CANNULATION USING TEXTURE AND COLOR ENHANCEMENT IMAGING (TXI) IN PATIENTS WITH ROUX-EN-Y AFTER GASTRECTOMY" LITERATURE SUMMARY DEEP INTUBATION OF THE BILE DUCT UNDER BALLOON ENDOSCOPY IS NOT EASY FOR PATIENTS WITH ROUX-EN-Y AFTER GASTRECTOMY. TEXTURE AND COLOR ENHANCEMENT IMAGING (TXI), WHICH IS INCORPORATED IN THE RECENTLY INTRODUCED ENDOSCOPIC SYSTEM EVIS X1 (OLYMPUS), OPTIMIZES THE STRUCTURE, COLOR TONE, AND BRIGHTNESS OF THE MUCOSA, ENHANCES SLIGHT CHANGES IN COLOR TONE AND STRUCTURE, IMPROVES THE IDENTIFICATION OF THE PAPILLARY REGION, AND MAY BE USEFUL FOR DEEP BILE DUCT IT HAS BEEN REPORTED THAT THIS TECHNIQUE MAY BE USEFUL FOR DEEP INTUBATION OF THE BILE DUCT. WE INVESTIGATED THE USEFULNESS OF DEEP BILE DUCT INTUBATION USING TXI IN PATIENTS WITH ROUX-EN-Y AFTER GASTRECTOMY. THE FOLLOWING EVENTS HAVE BEEN REPORTED IN THE LITERATURE: PANCREATITIS -7. CHOLANGITIS-2. INTESTINAL PERFORATION (MODERATE)-3.

  Patient problems: Cholangitis; Pancreatitis; Perforation

  MAUDE report 19563638 ↗
• MalfunctionNov 8, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE DISPOSABLE BENDING CANNULA WAS BEING USED AS PART OF AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE. THE CUSTOMER REPORTED THE WIRE AT THE TIP OF THE SHEATH BROKE SOON AFTER INSERTION AND THE TIP STOPPED WORKING. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THE CUSTOMER REPORTED THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES FOUND. THERE WERE NO ADVERSE EFFECTS TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18093052 ↗
• InjuryApr 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED, "SINGLE-OPERATOR PERORAL CHOLANGIOSCOPY CYSTIC DUCT CANNULATION FOR TRANSPAPILLARY GALLBLADDER STENT PLACEMENT IN PATIENTS WITH ACUTE CHOLECYSTITIS AT MODERATE TO HIGH SURGICAL RISK (WITH VIDEOS)". BACKGROUND: ONE OF THE MAIN REASONS FOR FAILED ENDOSCOPIC TRANSPAPILLARY GALLBLADDER STENTING (ETGS) UNDER FLUOROSCOPIC GUIDANCE IS THE INABILITY TO CANNULATE THE CYSTIC DUCT. SINGLE-OPERATOR PERORAL CHOLANGIOSCOPY (SOC)-ASSISTED ETGS IS AN ADJUNCT TECHNIQUE TO FACILITATE ETGS. WE AIMED TO DEMONSTRATE ITS EFFICACY. METHODS: BETWEEN 2015 AND 2019, 104 PATIENTS WITH ACUTE CHOLECYSTITIS AT MODERATE TO HIGH SURGICAL RISK UNDERWENT ETGS, WHICH INVOLVED 3 STEPS: (1) CYSTIC DUCT CANNULATION UNDER FLUOROSCOPIC GUIDANCE WITH OR WITHOUT ADDITIONAL SOC GUIDANCE; (2) GUIDEWIRE PLACEMENT; AND (3) STENT PLACEMENT IN THE GALLBLADDER. THE TECHNICAL SUCCESS RATE WAS DETERMINED WHEN STENT PLACEMENT WAS CONFIRMED ENDOSCOPICALLY AND RADIOGRAPHICALLY. RESULTS: OF 104 PATIENTS, 55 (53%) PATIENTS HAD SUCCESSFUL ETGS UNDER FLUOROSCOPIC GUIDANCE. OF 49 PATIENTS WHO HAD FAILED FLUOROSCOPY-GUIDED ETGS, 41 PATIENTS UNDERWENT ADDITIONAL SOC-ASSISTED ETGS AND 5 PATIEN

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pancreatitis; Perforation

  MAUDE report 16679177 ↗
• InjuryFeb 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE, "INVESTIGATION OF ENDOSCOPIC TRANSPAPILLARY GALLBLADDER DRAINAGE FOR ACUTE CHOLECYSTITIS-TECHNICAL TIPS FOR DIFFICULT CASES OF CYSTIC DUCT INFUSION". ENDOSCOPY FOR ACUTE CHOLECYSTITIS MIRROR TRANSPAPILLARY CYSTIC DUCT DRAINAGE (ETGBD) IS EFFECTIVE IN CASES OF ASCITES AND BLEEDING TENDENCY. HOWEVER, COMPARED TO OTHER ERCP-RELATED PROCEDURES, ETGBD HAS A LOW SUCCESS RATE AND OFTEN ENCOUNTERS SITUATIONS WHERE IT IS DIFFICULT TO COMPLETE THE PROCEDURE. THIS TIME, WE EXAMINED THE TREATMENT RESULTS OF ETGBD FOR ACUTE CHOLECYSTITIS IN OUR HOSPITAL. IT ALSO INTRODUCES TECHNICAL TIPS FOR TREATMENT. A RETROSPECTIVE STUDY WAS CONDUCTED ON 41 PATIENTS WHO UNDERWENT ETGBD FOR ACUTE CHOLECYSTITIS AT OUR HOSPITAL BETWEEN JANUARY 2015 AND JULY 2021. THERE WERE 28 MALES AND 13 FEMALES WITH A MEDIAN AGE OF 80 YEARS (58-91), AND THE SEVERITY OF DISEASE WAS MILD IN 27 PATIENTS (65.9%), MODERATE IN 13 (31.7%), AND SEVERE IN 1 (2.4%). INTRACOLONIC, DUCTAL, AND COMMON BILE DUCT STONES WERE FOUND IN 30 (73.2%), 13 (31.7%), AND 16 (39.0%) PATIENTS, RESPECTIVELY. THE BIFURCATION OF THE ILEOCECAL DUCT WAS AS FOLLOWS: HIGH/LOW: 36/5, HEAD/FOOT: 35/6, RIGHT SIDE/LEFT

  Patient problems: Perforation

  MAUDE report 13603699 ↗