Single Use Mechanical Lithotriptor V BML-V437QR-30 (UDI 04953170218415)Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 04953170218415), received between Sep 27, 2019 and May 15, 2026 — classified as 19 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2026Failure to Cut; Mechanical Jam

  IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THIS SINGLE USE MECHANICAL LITHOTRIPTOR BASKET FAILED TO CRUSH A STONE. THE PHYSICIAN THEN USED THE EMERGENCY HANDLE. THE STONE WAS CRUSHED AND THE BASKET WAS RETRIEVED FROM THE PATIENT. THERE WERE NO FURTHER REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25191988 ↗
• InjuryMar 5, 2026Break; Difficult to Remove; Mechanical Jam

  IT WAS REPORTED THAT DURING AN ELECTIVE AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE UNDER SEDATION WITH PROPOFOL, THE LOCKING ROD OF THE SINGLE USE MECHANICAL LITHOTRIPTOR BROKE DIRECTLY AT THE END OF THE BML HANDLE, AND REST REMAINED STUCK IN THE HANDLE DURING MECHANICAL LITHOTRIPSY. THE BASKET BROKE OFF FROM THE DEVICE AND REMAINED IN THE PATIENT, WITH THE WIRES STILL ATTACHED AND ACCESSIBLE IN CONTACT WITH THE BASKET. THE BASKET ITSELF HAD ENCLOSED A LARGE INTRADUCTAL CALCULUS AND COULD NOT INITIALLY BE REMOVED FROM THE DHC. AN EMERGENCY LITHOTRIPSY SET FROM A THIRD-PARTY COMPANY WAS THEN USED. THE WIRES WERE INSERTED INTO THIS DEVICE AND THE STONE WAS LITHOTRIPSIED, AND THE DEFECTIVE BASKET WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT BY PULLING IT OUT BY WIRES OF THE OTHER DEVICE BUT THE CONCRETIONS REMAINED INSIDE THE BILE DUCT. THE PATIENT THEN UNDERWENT FURTHER TREATMENT, INCLUDING STENT PLACEMENT AND PLAN A CHOLANGIOSCOPY WITH EHL. THE PROCEDURE WAS COMPLETED WITH A SIGNIFICANT DELAY OF APPROXIMATELY 40 MINUTES THE PATIENT REMAINED HEMODYNAMICALLY STABLE. THERE WERE NO REPORTS OF PATIENT HARM OR COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24525833 ↗
• InjuryFeb 18, 2026Break; Detachment of Device or Device Component

  NO RELEVANT ADDITIONAL INFORMATION SUBMITTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24378347 ↗
• MalfunctionMay 29, 2025Break; Break

  IT WAS REPORTED THE SUBJECT DEVICE BASKET¿S STEM SNAPPED WHILE ATTEMPTING TO CRUSH A BILIARY STONE. THIS ISSUE OCCURRED DURING A UNKNOWN THERAPEUTIC PROCEDURE. THE EMERGENCY HANDLE WAS THEN USED TO COMPLETE THE PROCEDURE. WHILE USING THE EMERGENCY HANDLE TO CRUSH THE STONE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22109898 ↗
• InjuryJul 17, 2024Break; Break

  IT WAS REPORTED, DURING THE THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) BILIARY LITHOTRIPSY, WHEN USING A COMBINATION OF THE SINGLE USE MECHANICAL LITHOTRIPTOR AND THE BML HANDLE, THE WIRE OF THE PRODUCT BROKE, MAKING IT IMPOSSIBLE TO PERFORM TREATMENT. THE RATCHET BECAME LIGHTER, BUT THE STONE WAS NOT BROKEN. WHEN THE EQUIPMENT WAS CHECKED, IT WAS FOUND TO HAVE BROKEN AT THE JOINT BETWEEN THE HAND WIRE AND THE BASKET WIRE. THE STONE COULD NOT BE CRUSHED, AND THE STONE REMAINED IN THE BASKET, RESULTING IN IMPACTION. THE PROCEDURE WAS EXTENDED BY 40 MINUTES AND THERE WAS NO ADDITIONAL ADMINISTRATION OF ANESTHESIA. THE PROCEDURE WAS COMPLETED BY USING A RETRIEVAL BALLOON NEXT TO THE IMPACTED BASKET, REMOVING THE STONE FROM THE BASKET, AND RELEASING THE IMPACTION. THE USER CHANGED TO A POLICY OF PLACING AN ENDOSCOPIC NASOBILIARY DRAINAGE (ENBD) TUBE AND OBSERVING THE PROGRESS. THE TREATMENT HAS NOT BEEN COMPLETED AND WILL BE CARRIED OUT AT A LATER DATE. THE RATCHET AND TWO LOCKS WERE INSPECTED BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19760476 ↗
• MalfunctionJul 12, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THE LITHOTRIPTOR HAD A TORN GUIDEWIRE TIP. IT DID NOT FALL INSIDE THE BODY. THE ISSUE WAS DETECTED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19729814 ↗
• MalfunctionJul 12, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THE LITHOTRIPTOR HAD A TORN GUIDEWIRE TIP. NO PARTS WERE LOST INSIDE THE BODY. THE ISSUE WAS DETECTED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19729645 ↗
• MalfunctionApr 25, 2024Break; Break

  IT WAS REPORTED, THE DISTAL GUIDEWIRE TIP OF THE SINGLE USE MECHANICAL LITHOTRIPTOR WAS BROKEN. THE ISSUE OCCURRED DURING PREPARATION FOR USE FOR AN UNSPECIFIED THERAPEUTIC PROCEDURE, WHICH WAS COMPLETED WITH A SIMILAR DEVICE WITH NO REPORTS OF DELAY. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19181813 ↗
• InjuryMar 8, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THE SINGLE USE MECHANICAL LITHOTRIPTER BECAME INCARCERATED DURING THE THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) LITHOTRIPSY PROCEDURE. THE HAND PART WAS BROKEN. ALTHOUGH A VANBECK HANDLE WAS USED, THE WIRE BROKE INSIDE THE SHEATH AND THE INCARCERATION COULD NOT BE RELEASED. IT WAS REPORTED THAT A NON-OLYMPUS BASKET WAS INCARCERATED FIRST, AND THEN THE OLYMPUS BASKET WAS ALSO INCARCERATED. THE BILE DUCT STONE WAS REPORTED TO BE VERY HARD. THE PROCEDURE AND THE PATIENT'S ANESTHESIA/SEDATION WAS EXTENDED HALF AN HOUR AND THE ERCP LITHOTRIPSY WAS NOT COMPLETED AS THE PATIENT WAS TRANSFERRED TO SURGERY. AFTER SURGERY, THE CHOLECYSTECTOMY/LITHOTOMY/REMOVAL OF THE FOREIGN BODY (REMAINING BASKET) WAS COMPLETED, AND THE PATIENT WAS IN THE HOSPITAL RECOVERING FROM THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18866566 ↗
• MalfunctionMar 8, 2024Material Separation; Material Separation

  NO UNSCHEDULED ADDITIONAL MEASURES WERE PERFORMED, AND THE PLANNED PROCEDURE WAS COMPLETED BY REPLACING THE CRUSHER WITH ANOTHER DEVICE. THE SUBJECT DEVICE WAS REMOVED THROUGH THE FORCEPS PORT AS USUAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18865760 ↗
• MalfunctionFeb 26, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  THE REPORTED ISSUE OCCURRED DURING A THERAPEUTIC PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18784305 ↗
• InjuryFeb 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "ADDITION OF MECHANICAL LITHOTRIPSY TO ENDOSCOPIC PAPILLARY LARGE BALLOON DILATION IN PATIENTS WITH DIFFICULT COMMON BILE DUCT STONES: A RETROSPECTIVE SINGLE-CENTER STUDY."     ¿LITERATURE SUMMARY¿ THIS RETROSPECTIVE STUDY AIMED TO COMPARE THE TREATMENT OUTCOMES OF ENDOSCOPIC PAPILLARY LARGE-BALLOON DILATION (EPLBD) WITH AND WITHOUT MECHANICAL LITHOTRIPSY (ML) IN REMOVING DIFFICULT COMMON BILE DUCT STONES. A TOTAL OF 122 PATIENTS WERE INCLUDED (N = 44, EPLBD + ML AND N = 78, EPLBD). COMPARED WITH THE EPLBD GROUP, THE EPLBD + ML GROUP REQUIRED MORE ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURES (¿2) (86% VERSUS 67%) AND LONGER TOTAL ERCP TIME AFTER REACHING THE PAPILLA (78.5 MINUTES VERSUS 25 MINUTES). METHODS: PATIENTS WITH DIFFICULT COMMON BILE DUCT STONES TREATED WITH EPLBD, WITH OR WITHOUT ML, AT THE (B)(6) CENTER BETWEEN (B)(6) 2014 AND (B)(6) 2020, WERE RETROSPECTIVELY EVALUATED. THE RATES OF CUMULATIVE RECURRENCE AND COMPLICATIONS WERE COMPARED BETWEEN THE TWO GROUPS. RESULTS: OVERALL, 122 PATIENTS (N = 44, EPLBD + ML AND N = 78, EPLBD) TREATED BY 12 GASTROENTEROLOGISTS WERE INCLUDED. PATIENTS

  Patient problems: Cholangitis; Pancreatitis

  MAUDE report 18743701 ↗
• InjuryDec 16, 2023Break; Break

  THE OLYMPUS EMPLOYEE REPORTED ON BEHALF OF THE CUSTOMER THAT THE OPERATING WIRE BROKE OFF ON THE SINGLE USE MECHANICAL LITHOTRIPTOR IN THE MIDDLE OF A THERAPEUTIC ERCP ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN AN 80 YEAR OLD FEMALE PATIENT. THE WIRE WAS CUT WITH PLIERS AND BASKET WAS REMOVED FROM THE PATIENT. THE PROCEDURE COULD NOT BE COMPLETED. AS SUCH, ENDOSCOPIC PAPILLARY LARGE BALLOON DILATION WAS PERFORMED AND ENBD -ENDOSCOPIC NASAL BILIARY DRAINAGE TUBE WERE USED TO COMPLETE THE PROCEDURE. A DELAY OF 20 MINUTES WAS REPORTED BUT NO IMPACT TO THE PATIENT. NO HEALTH HAZARDS TO THE PATIENT WERE REPORTED AND NO PRE-EXISTING CONDITIONS WERE KNOWN. IT IS UNKNOWN IF ADDITIONAL SEDATION WAS REQUIRED, OR ANY ADDITIONAL INTERVENTIONS UNDERTAKEN. PATIENTS CURRENT CONDITION IS UNKNOWN. THE CUSTOMER REPORTED THAT THEY PLAN TO CONDUCT AN ERCP (WITH ENDOSCOPIC NASAL BILIARY DRAINAGE) AT A LATER DATE. THE DEVICE WAS INSPECTED PRIOR TO USE AND WAS FOUND TO BE OKAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18341614 ↗
• MalfunctionNov 2, 2023Separation Problem; Separation Problem

  AN OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THAT WHEN USING A SINGLE USE MECHANICAL LITHOTRIPTOR V, THE HANDLE STOPPED TURNING BEFORE THE GALLSTONE COULD BE GRIPPED FIRMLY. THE STEERING WHEEL COULD NOT TURN FORWARD OR BACKWARD. THE USER PRESSED THE UNLOCK BUTTON AND SEPARATED THE BASKET FROM THE HANDLE, THEN REMOVED THE BASKET FROM THE BODY. THE THERAPEUTIC PROCEDURE (LITHOTRIPSY OF BILE DUCT STONES) WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS A PROCEDURAL DELAY OF AN UNKNOWN PERIOD OF TIME TO SWITCH DEVICES. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18058628 ↗
• InjuryNov 2, 2023Break; Break

  THE OLYMPUS EMPLOYEE REPORTED ON BEHALF OF THE CUSTOMER THAT DURING THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) LITHOTRIPSY PROCEDURE THE USER TRIED CRUSHING THE STONES USING THE BML-V437QR-30-SINGLE USE MECHANICAL LITHOTRIPTOR V, THE BASKET SHAFT ON THE HANDLE NEAR THE OPERATION PART BROKE AND CAME OFF WITHOUT APPLYING A LOT OF PRESSURE. THE USER WAS UNABLE TO RETRIEVE THE BASKET WHEN CLUTCHING THE STONES AND REMOVED THE OUTER COIL SHEATH, LEAVING ONLY THE WIRE, AND THEREFORE USED THE VANBECK HANDLE TO BREAK THE STONES. BY ENDOSCOPIC VISUAL INSPECTION IT WAS ENSURED THAT ALL THE STONES WERE COMPLETELY RETRIEVED ALONG WITH THE BASKET AND NO PART INSIDE PATIENT.THE PROCEDURE WAS COMPLETED BY THE SAME SET OF EQUIPMENT. THE PROCEDURE WAS REPORTEDLY EXTENDED (UNKNOWN DELAY) AND UNKNOWN IF ADDITIONAL ANESTHESIA WAS REQUIRED. NO ADDITIONAL MEDICAL OR DIAGNOSTIC INTERVENTIONS WERE UNDERTAKEN. THE PATIENT CURRENT CONDITION, OUTCOME DUE TO THE PROCEDURE AND PRE-EXISTING CONDITIONS ARE UNKNOWN. NO HEALTH DAMAGE TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18057519 ↗
• InjuryOct 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED FROM THE AUTHOR CONFIRMS THIS EVENT WAS NOT CAUSED BY AN OLYMPUS DEVICE AND THERE IS NO MALFUNCTION IN OLYMPUS DEVICE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pancreatitis; Perforation; Peritonitis

  MAUDE report 17877905 ↗
• InjuryAug 29, 2023Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  THE OLYMPUS EMPLOYEE REPORTED ON BEHALF OF THE CUSTOMER THAT DURING A THERAPEUTIC LITHOTRIPSY PROCEDURE THE GUIDE WIRE TIP OF SINGLE USE MECHANICAL LITHOTRIPTOR V BROKE AND GOT STUCK IN THE DUODENUM. THE PHYSICIAN MANAGED TO RECOVER THE STUCK PIECE OF DEBRIS. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION ON HOW THE BROKEN PIECES WERE RETRIEVED AND PATIENT OUTCOME HAS BEEN REQUESTED BUT THE INFORMATION HAS NOT BEEN RECEIVED.

  Patient problems: Bowel Perforation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17642488 ↗
• MalfunctionAug 14, 2023Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO OLYMPUS, DURING A THERAPEUTIC PROCEDURE WITH THE SINGLE USE MECHANICAL LITHOTRIPTOR V, A STONE WAS HARD AND WAS TEMPORARILY ¿INCARCERATED¿. SUBSEQUENTLY, THE STONE WAS CRUSHED WITH A HANDLE AND THE INTENDED PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17540203 ↗
• InjuryAug 7, 2023Difficult to Remove; Difficult to Remove

  THE CUSTOMER REPORTED TO OLYMPUS THAT WHILE USING A SINGLE USE MECHANICAL LITHOTRIPTOR V, GALL STONES WERE STUCK IN THE BASKET TEMPORARILY BUT WERE ABLE TO BE FREED FROM THE BASKET AFTER THE WIRES WERE CUT. THE LITHOTRIPTOR WAS THEN WITHDRAWN. THE ISSUE WAS FOUND DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, WHICH WAS COMPLETED WITH THE DEVICE WITHOUT SIGNIFICANT DELAY. THERE WERE NO REPORTS OF ADDITIONAL IMPACT TO THE PATIENT. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17476151 ↗
• InjuryJul 12, 2023Difficult to Remove; Difficult to Remove

  THE OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT DURING A THERAPEUTIC ENDOSCOPIC BILE DUCT STONE REMOVAL WITH A SINGLE USE MECHANICAL LITHOTRIPTOR V, THE STONE WAS MORE FIRMLY INCARCERATED THAN EXPECTED, AND THE WIRE WAS CUT NEAR THE CONTROL UNIT AND WAS STICKING OUT OF THE PATIENT¿S MOUTH. THE PROCEDURE WAS ABORTED SINCE THE STONE COULD NOT BE REMOVED, AND A SURGICAL OPERATION WAS PERFORMED TWO DAYS LATER AND THE STONE WAS SUCCESSFULLY REMOVED. THE DEVICE WAS INSPECTED BEFORE USE AND APPEARED TO BE NORMAL. THERE WAS NO IMPACT ON THE PATIENT OR PROCEDURE AND NO HEALTH HAZARD REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17311315 ↗
• MalfunctionJun 26, 2023Break; Break

  THE CUSTOMER REPORTED THAT CRUSHING A BILE DUCT STONE WITH THE SINGLE USE MECHANICAL LITHOTRIPTOR V WAS DIFFICULT BECAUSE THE STONE WAS HARD. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE. WHEN THE CUSTOMER TURNED THE KNOB OF THE HANDLE FORCEFULLY, THE CONNECTING PART BETWEEN THE LITHOTRIPTOR SHEATH AND HANDLE BROKE. BOTH PARTS WERE NOTED TO BE BROKEN. THE LITHOTRIPTOR WAS REMOVED EXCEPT FOR THE BASKET. THE CRUSHED STONE WAS COMPLETED USING ANOTHER DEVICE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17200401 ↗
• InjuryJun 14, 2023Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  THE OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT DURING THE ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE (THERAPEUTIC), THE SINGLE USE MECHANICAL LITHOTRIPTOR V FRACTURED DURING LITHOTRIPSY AND THE TIP FELL OFF. THE BROKEN POINT WAS THE BASE OF THE BASKET. THE OPERATING SIDE PART OF THE STONE CRUSHER WAS CUT, AND THE SCOPE WAS REMOVED ONCE AND REINSERTED. AFTER THAT, THE BILE DUCT WAS EXPANDED WITH A BALLOON, AND THE REMOVAL OF THE BASKET WAS COMPLETED. THERE WAS A FORTY-FIVE MINUTE PROCEDURE EXTENSION. THE PROCEDURE WAS COMPLETED USING THE SAME SET OF EQUIPMENT. THERE WERE NO REPORTS OF HEALTH HAZARD ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17132172 ↗
• MalfunctionMar 28, 2023Mechanical Problem; Difficult to Remove; Mechanical Problem; Difficult to Remove

  THE CUSTOMER REPORTED TO OLYMPUS, THE SINGLE USE MECHANICAL LITHOTRIPTOR V WAS INCARCERATED AND THE BASKET COULD NOT BE REMOVED DURING AN ENDOSCOPIC MECHANICAL LITHOTRIPSY (EML) PROCEDURE. THE LITHOTRIPTOR WAS WITHDRAWN TOGETHER WITH THE SCOPE. ANOTHER SCOPE AND LITHOTRIPTOR WERE USED TO COMPLETE THE PROCEDURE. THERE WAS A DELAY IN PROCEDURE AND THE PATIENT WAS UNDER SEDATION AT THE TIME OF DELAY. DURATION OF DELAY WAS UNKNOWN. THE LITHOTRIPTOR SHEATH WAS CAUGHT IN THE FORCEPS ELEVATOR OF THE SCOPE AND THE SHEATH COULD NOT BE REMOVED FROM THE BML HANDLE. THE DEVICE WAS INSPECTED BEFORE USAGE AND THERE WERE NO ISSUES. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THE EVENT. THIS REPORT CAPTURES THE COMPLAINT ON THE LITHOTRIPTOR (MODEL: BML-V437QR-30, MODEL DESCRIPTION: SINGLE USE MECHANICAL LITHOTRIPTOR V ). PATIENT IDENTIFIER (B)(6) CAPTURES COMPLAINT ON THE SCOPE (MODEL : JF-260V, MODEL DESCRIPTION : EVIS LUCERA DUODENOVIDEOSCOPE , SERIAL NUMBER : (B)(4). PATIENT IDENTIFIER (B)(6) CAPTURES COMPLAINT ON THE BML HANDLE (MODEL: MAJ-441, MODEL DESCRIPTION: BML HANDLE V).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16626338 ↗
• InjuryJan 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED, "BALLOON ENTEROSCOPY-ASSISTED ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY FOR THE TREATMENT OF COMMON BILE DUCT STONES IN PATIENTS WITH ROUX-EN-Y GASTRECTOMY: OUTCOMES AND FACTORS AFFECTING COMPLETE STONE EXTRACTION." THIS RETROSPECTIVE STUDY INVESTIGATED THE TREATMENT OUTCOMES AND POTENTIAL FACTORS AFFECTING COMPLETE STONE EXTRACTION IN 79 PATIENTS. THE INITIAL SUCCESS RATES OF REACHING THE PAPILLA OF VATER, BILIARY CANNULATION, AND BILIARY INTERVENTION, INCLUDING COMPLETE STONE EXTRACTION OR BILIARY STENT PLACEMENT, WERE 92%, 81%, AND 78%, RESPECTIVELY. THE MULTIVARIATE ANALYSIS INDICATED THAT THE LARGEST CBD DIAMETER = 14 MM (ODDS RATIO (OR), 0.04; 95% CONFIDENCE INTERVAL (CI), 0.01¿0.58) AND RETROFLEX POSITION (OR, 6.43; 95% CI, 1.12¿36.81) WERE INDEPENDENT PREDICTIVE FACTORS AFFECTING COMPLETE STONE EXTRACTION ACHIEVEMENT. THIS STUDY CONCLUDES THAT THERAPEUTIC SDBE-ERCP FOR CBD STONES IN A RELATIVELY ELDERLY RYG COHORT, WAS EFFECTIVE AND SAFE. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS MILD PERFORATION - 1 PATIENT MODERATE PERFORATION - 1 PATIENT MILD PANCREATITIS - 1 PATIENT MILD HYPOXIA - 1 PATIENT THIS WAS A MULTI-CENTER R

  Patient problems: Hypoxia; Pancreatitis; Perforation

  MAUDE report 16127150 ↗
• InjuryJan 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED, "BALLOON ENTEROSCOPY-ASSISTED ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY FOR THE TREATMENT OF COMMON BILE DUCT STONES IN PATIENTS WITH ROUX-EN-Y GASTRECTOMY: OUTCOMES AND FACTORS AFFECTING COMPLETE STONE EXTRACTION." THIS RETROSPECTIVE STUDY INVESTIGATED THE TREATMENT OUTCOMES AND POTENTIAL FACTORS AFFECTING COMPLETE STONE EXTRACTION IN 79 PATIENTS. THE INITIAL SUCCESS RATES OF REACHING THE PAPILLA OF VATER, BILIARY CANNULATION, AND BILIARY INTERVENTION, INCLUDING COMPLETE STONE EXTRACTION OR BILIARY STENT PLACEMENT, WERE 92%, 81%, AND 78%, RESPECTIVELY. THE MULTIVARIATE ANALYSIS INDICATED THAT THE LARGEST CBD DIAMETER = 14 MM (ODDS RATIO (OR), 0.04; 95% CONFIDENCE INTERVAL (CI), 0.01¿0.58) AND RETROFLEX POSITION (OR, 6.43; 95% CI, 1.12¿36.81) WERE INDEPENDENT PREDICTIVE FACTORS AFFECTING COMPLETE STONE EXTRACTION ACHIEVEMENT. THIS STUDY CONCLUDES THAT THERAPEUTIC SDBE-ERCP FOR CBD STONES IN A RELATIVELY ELDERLY RYG COHORT, WAS EFFECTIVE AND SAFE. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS, MILD PERFORATION - 1 PATIENT, MODERATE PERFORATION - 1 PATIENT, MILD PANCREATITIS - 1 PATIENT, MILD HYPOXIA - 1 PATIENT. THIS WAS A MULTI-CEN

  Patient problems: Hypoxia; Pancreatitis; Perforation

  MAUDE report 16126769 ↗