Single Use Retrieval Nitinol Basket V FG-V451PRecalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 04953170395321), received between Nov 9, 2021 and Apr 5, 2026 — classified as 10 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• InjuryApr 5, 2026Entrapment of Device; Separation Failure

  IT WAS REPORTED THAT DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY INVOLVING COMPLEX ANATOMY, THE SINGLE USE RETRIEVAL NITINOL BASKET V DID NOT BREAK AT THE PREDETERMINED BREAKING POINT; AS A RESULT, THE STONE COULD NOT BE FRAGMENTED, AND THE BASKET REMAINED INSIDE THE PATIENT. THE PROCEDURE WAS PROLONGED BY GREATER THAN OR EQUAL TO 30 MINUTES. ON (B)(6) 2025, THE PATIENT UNDERWENT ANOTHER PROCEDURE, DURING WHICH BOTH THE BASKET THAT HAD REMAINED INSIDE THE PATIENT AND THE STONE WERE SUCCESSFULLY REMOVED. THERE WERE NO REPORTS OF FURTHER PATIENT HARM.

  Patient problems: Foreign Body In Patient

  MAUDE report 24786826 ↗
• InjuryDec 10, 2025Entrapment of Device; Fracture; Failure to Advance; Material Twisted/Bent; Entrapment of Device; Fracture; Failure to Advance; Material Twisted/Bent

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23774760 ↗
• MalfunctionMar 14, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THE SUBJECT DEVICE THEY ATTEMPTED TO PULL THE BASKET BACK INTO THE SHEATH, BUT IT WOULD NOT OPEN. THEY THEN REMOVED THE SCOPE AND EXTRACTED THE DEVICE, YET IT STILL FAILED TO REOPEN. THE PROCEDURE WAS COMPLETED USING A BACKUP DEVICE. THIS IS OCCURRED DURING A THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21606088 ↗
• InjuryOct 2, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) THE STONE BECAME IMPACTED WHILE USING THE SINGLE USE RETRIEVAL BASKET. THE CUSTOMER ATTEMPTED TO AVOID THE IMPACTION BY USING A LITHOTRIPTOR AND EMERGENCY HANDLE, BUT THE CENTER WIRE OF THE RETRIEVAL BASKET MADE A LOOP AND THE COIL SHEATH OF THE LITHOTRIPTOR COULD NOT BE ADVANCED. THE DOCTOR STATED THE RING SECTION OF THE CENTER WIRE OF THE RETRIEVAL BASKET WAS DEFORMED BECAUSE THE COIL SHEATH BENT TOO SHARPLY WHEN IT ENTERED THE BILE DUCT. THE WIRE THEN BROKE WHEN THE EMERGENCY HANDLE WAS USED. THE CUSTOMER THEN USED A DUODENOVIDEOSCOPE AND SPYGLASS TO PERFORM ELECTROHYDRAULIC LITHOTRIPSY (EHL) TO BREAK UP THE STONE AND RELEASE THE IMPACTION. THE PROCEDURE WAS THEN COMPLETED. THE EVENT EXTENDED THE PROCEDURE TIME BY 2 HOURS AND 30 MINUTES. THERE WAS NO HEALTH DAMAGE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20355037 ↗
• MalfunctionSep 9, 2024Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE RETRIEVAL NITINOL BASKET COULD NOT BE RETRACTED AFTER SEVERAL ATTEMPTS TO EXTRACT STONES. THE ISSUE OCCURRED DURING AN UNKNOWN THERAPEUTIC PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20177281 ↗
• MalfunctionSep 9, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE, WHEN TRYING TO SCRAPE OUT A STONE USING THE SINGLE USE RETRIEVAL NITINOL BASKET V, THE STONE BECAME TEMPORARILY IMPACTED AND THE WIRE STRETCHED OUT. THE STONE WAS THEN RELEASED, AND THE PROCEDURE WAS COMPLETED USING THE SAME SET OF EQUIPMENT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20176554 ↗
• MalfunctionAug 20, 2024Collapse; Collapse

  IT WAS REPORTED THE SINGLE USE RETRIEVAL BASKET WAS CRUSHED AND WOULD NOT CLOSE WHEN THE DEVICE WAS CHECKED FOR OPENING AND CLOSING. THE ISSUE OCCURRED DURING PREPARATION FOR USE FOR A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP). 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 20005392 ↗
• MalfunctionJun 4, 2024Break; Break

  IT WAS REPORTED THE BASKET WIRE WAS BROKEN. THE ISSUE OCCURRED 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 19460430 ↗
• InjuryFeb 23, 2024Break; Break

  IT WAS REPORTED BALLOON RUPTURED DURING BALLOON SWEEP INVOLVING STONES. THE SINGLE USE RETRIEVAL BASKET BROKE. THE ISSUE OCCURRED WHEN THE BASKET WAS PLACED INTO THE DUCT TO RETRIEVE STONES DURING A THERAPEUTIC PROCEDURE. THE BASKET COULD NOT BE REMOVED DUE TO THE STONES, SO THE BASKET WAS CONNECTED TO THE EMERGENCY HANDLE, WHICH WAS WHEN THE BASKET BROKE. THE BASKET WAS THEN REMOVED WITH THE AID OF A EMERGENCY HANDLE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18773128 ↗
• InjuryFeb 23, 2024Break; Break

  THE CUSTOMER REPORTED THE SINGLE USE RETRIEVAL BASKET BROKE. THE ISSUE OCCURRED WHEN THE BASKET WAS PLACED INTO THE DUCT TO RETRIEVE STONES DURING A THERAPEUTIC PROCEDURE. THE BASKET COULD NOT BE REMOVED DUE TO THE STONES SO THE BASKET WAS CONNECTED TO THE EMERGENCY HANDLE, WHICH WAS WHEN THE BASKET BROKE. THE BASKET WAS THEN REMOVED. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18765854 ↗
• MalfunctionJan 17, 2024Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, THAT THE RETRIEVAL NITINOL BASKET BROKE WHEN QUARRYING A STONE INSIDE THE BILE DUCT. IT WAS REPORTED THAT WHEN MOVED IT UP AND DOWN TO TAKE IN THE STONE, THE STRUT STRETCHED INSIDE THE BILE DUCT AND TWISTED INTO A U-SHAPE. THE ISSUE WAS FOUND DURING A THERAPEUTIC PROCEDURE. THE CUSTOMER NOTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18530987 ↗
• InjuryDec 1, 2023Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  OLYMPUS RECEIVED FURTHER INFORMATION INDICATING THAT THE PATIENT DID NOT HAVE ANY COMPLICATIONS FROM THE INCARCERATION. THE PATIENT WAS HOSPITALIZED IN THE FACILITY WHERE THE BASKET WAS REMOVED BUT WAS NOT ADMITTED TO THE ICU. THE PATIENT HAS RECOVERED AND HAS BEEN DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18247591 ↗
• MalfunctionOct 25, 2023Difficult to Open or Close; Difficult to Open or Close

  THE CUSTOMER REPORTED TO OLYMPUS THAT WHILE USING THE SINGLE USE RETRIEVAL NITINOL BASKET V, THE BASKET WOULD NO LONGER OPEN OR CLOSE. THE ISSUE WAS FOUND DURING A PROCEDURE THAT WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18006773 ↗
• MalfunctionSep 5, 2023Break; Break

  IT WAS REPORTED THAT THE SINGLE USE RETRIEVAL BASKET WIRE BROKE DURING A THERAPEUTIC ENDOSCOPIC BILE DUCT STONE REMOVAL. THERE WAS A BREAK IN THE CENTER WIRE AND THE DEVICE DID NOT WORK WELL, MAKING IT IMPOSSIBLE TO COLLECT STONES. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE AND THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17684770 ↗
• MalfunctionAug 28, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE SINGLE USE RETRIEVAL NITINOL BASKET V WAS UNABLE TO COLLECT THE STONES. THE EVENT OCCURRED DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT. THE DEVICE WAS EVALUATED, AND IT WAS FOUND THAT THE LOOP AT THE BASE OF THE BASKET CENTER WIRE WAS BROKEN. THIS MDR (MEDICAL DEVICE REPORT) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17631657 ↗
• InjuryMay 31, 2023Break; Break

  THE OLYMPUS ENDOSCOPY ACCOUNT MANAGER (EAM) CONFERENCED THE OLYMPUS TECHNICAL SUPPORT ENGINEER (TSE) AND THE CUSTOMER CONTACT WHO WAS IN THE PROCEDURE DURING THE CALL. THE CUSTOMER REPORTED THAT THE LITHOCRUSH WIRE BASKET BROKE (NO SPECIFIC MODEL OR LOT NUMBER WAS PROVIDED). THE CUSTOMER REPORTED THEY WERE ATTACHING THE EMERGENCY HANDLE AND THAT IS WHEN THE WIRE BROKE. THE PATIENT WAS SENT TO THE SURGERY TO HAVE THE BROKEN PIECE RETRIEVED. TO DATE, THE PATIENT WAS REPORTEDLY DOING WELL. THE CUSTOMER LATER CONFIRMED THE BASKET BROKE AT THE END OF THE THERAPEUTIC PROCEDURE. THERE WERE NO OTHER DEVICES INVOLVED. THE INTENDED PROCEDURE TO EXTRACT STONES, AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), WAS NOT COMPLETED AS PLANNED. AN OPEN ABDOMINAL EMERGENCY SURGERY WAS REQUIRED TO RETRIEVE THE BASKET AND STONES THAT FELL INSIDE THE PATIENT'S COMMON BILE DUCT. THE BASKET AND STONES WERE SUCCESSFULLY RETRIEVED AND THERE WERE NO FURTHER COMPLICATIONS. THE CUSTOMER ALSO REPORTED THE PATIENT HAD A SIGNIFICANTLY CONTRACTED GALLBLADDER WITH NECROSIS, ON THE DISTAL HALF (ENCOMPASSING THE INFUNDIBULUM), WHICH POSED A CHALLENGED TO THE PROCEDURE BEING PERFORMED. THE MFR MEDWATCH REPOR

  Patient problems: Insufficient Information

  MAUDE report 17035019 ↗
• InjuryApr 5, 2023Break; Difficult to Remove; Break; Difficult to Remove

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING A STONE EXTRACTION, THE SINGLE USE RETRIEVAL NITINOL BASKET V WAS INSERTED INTO THE FORCEPS CHANNEL OF THE EVIS LUCERA DUODENOVIDEOSCOPE TO GRASP THE STONE, AND WHEN THE SHEATH WAS PULLED WHILE THE BASKET WAS SLIGHTLY CLOSED, THE STONE WAS INCARCERATED. THE DOCTOR CUT THE FORCEPS AND CRUSHED THE STONE PER THE INSTRUCTION¿S MANUAL. THE THERAPEUTIC (STENTING) PROCEDURE WAS TERMINATED AND RESCHEDULED DUE TO THE BREAKAGE OF THE WIRE AFTER REMOVAL OF THE BILE/PANCREATIC DUCT STENT. THE PATIENT¿S CONDITION WAS NOT AFFECTED. THE THERAPEUTIC PROCEDURE WAS LATER COMPLETED WITH A SIMILAR DEVICE AND THERE WAS NO PATIENT HARM. THERE WAS NO REPORTED COMPLAINT FOR THE EVIS LUCERA DUODENOVIDEOSCPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16685850 ↗
• InjuryJan 12, 2023Break; Retraction Problem; Unintended Movement; Break; Retraction Problem; Unintended Movement

  A USER FACILITY REPORTED TO OLYMPUS THAT DURING CHOLEDOCHOLITHIASIS, ONE OF THE BASKET WIRES OF THE SINGLE USE RETRIEVAL NITINOL BASKET V WAS BROKEN. IT WAS DIFFICULT TO MOVE AND THE BASKET COULD NOT BE STORED IN THE SHEATH. IT IS UNKNOWN WHETHER IT WAS "INCARCERATED" OR IF THE TISSUE WAS SANDWICHED. THEY SURGEON TRIED TO DESTROY CALCULUS WITH A MECHANICAL LITHOTRIPTOR (BML-110A), BUT IT DID NOT INITIALLY WORK. NEXT, WHEN A CONTRAST MEDIUM WAS INJECTED TO EXPAND THE NIPPLE, THE BASKET FELL OUT OF THE "NIPPLE" (INTERPRETED TO BE THE AMPULLA OF VATER). THIS RESULTED IN A 4 HOUR SURGICAL DELAY. THE STONE WAS ULTIMATELY REMOVED, AND NO ADDITIONAL PROCEDURES WERE PERFORMED ON THE DAY OF THE PROCEDURE. THERE WERE ALSO NO ADDITIONAL PLANS FOR ANOTHER SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE PATIENT OUTCOME, BUT HAS NOT BEEN RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. PATIENT IDENTIFIER (B)(6) IS FOR THE SINGLE USE RETRIEVAL NITINOL BASKET V. PATIENT IDENTIFIER (B)(6) IS FOR THE MECHANICAL LITHOTRIPTOR.

  Patient problems: Intraoperative Pain; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16154057 ↗
• MalfunctionJan 10, 2023Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO OLYMPUS, THE SINGLE USE RETRIEVAL NITINOL BASKET V GOT CAUGHT ON THE FORCEPS ELEVATOR. THE OPEN BASKET WAS NOT PASSED THROUGH THE FORCEPS ELEVATOR AND THE BASKET CENTER WIRE WAS NOT STORED IN THE SHEATH. THE ISSUE WAS FOUND DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE AND THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16132157 ↗
• MalfunctionJan 5, 2023Material Deformation; Material Deformation

  THE CUSTOMER REPORTED TO OLYMPUS, THE SINGLE USE RETRIEVAL NITINOL BASKET V COULD NOT BE CLOSED BECAUSE THE TIP WIRE WAS DAMAGED WHILE BEING USED INSIDE THE PATIENT'S BODY. THE ISSUE WAS FOUND DURING A THERAPEUTIC STONE REMOVAL DURING ERCP PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16109699 ↗
• InjuryDec 13, 2022Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THAT DURING A STONE QUARRYING CASE, THE BASKET WIRE OF THE FG-V451P (SUBJECT DEVICE) GOT CAUGHT IN THE FORCEPS ELEVATOR OF THE TJF-260V SCOPE, MAKING IT IMPOSSIBLE TO REMOVE THE FORCEPS OR LOWER THE FORCEPS ELEVATOR. WHEN THE PHYSICIAN PULLED OUT THE SCOPE, WHILE THE FORCEPS ELEVATOR WAS STILL RAISED, THE PATIENT'S STOMACH WAS LACERATED AND BLEEDING OCCURRED. HEMOSTASIS WAS APPLIED, USING A CLIP, TO THE PART WHERE THE LACERATION OCCURRED. THE REPORTER STATED THAT THE PATIENT DID NOT RECEIVE A BLOOD TRANSFUSION. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE REPORTED EVENT, INCLUDING THE CURRENT STATUS OF THE PATIENT. THIS REPORT IS BEING SUBMITTED FOR THE FG-V451P (SINGLE USE RETRIEVAL NITINOL BASKET V), UNDER THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6). THE TJF-260V (EVIS LUCERA DUODENOVIDEOSCOPE) IS BEING SUBMITTED UNDER THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6).

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 15974458 ↗
• MalfunctionNov 19, 2022Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, THE BASKET WIRE BROKE WHEN THE WIRE WAS PULLED OUT FROM THE NIPPLE OF THE DISTAL END ASSEMBLY ON THE SINGLE USE RETRIEVAL NITINOL BASKET V. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. NO DEBRIS OR PARTS FELL INTO THE BODY. THERE WERE NO REPORTS OF PATIENT HARM. DURING THE EVALUATION IF WAS FOUND THAT THE WIRE BASKET WAS TEMPORARILY STUCK. THIS MEDWATCH REPORT IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15829763 ↗
• MalfunctionNov 4, 2022Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, DURING THE VERY BEGINNING OF A THERAPEUTIC GALLSTONE REMOVAL PROCEDURE, THERE WERE DIFFICULTIES IN DILATING THE PATIENT BILE DUCT WHICH DID NOT DILATE AS MUCH AS REQUIRED. A DECISION WAS MADE TO USE THE DEVICE FOR THE STONE REMOVAL. HOWEVER, THE DEVICE WAS STUCK WITH THE STONE IN THE DEVICE. THE DEVICE WIRES BROKE DOWN DURING TIGHTENING. NO PIECE FELL INTO THE PATIENT NOR DID ANY PIECE STICK OUT OR SEPARATE FROM THE DEVICE. THE DEVICE REMAINING WIRES AND END OF THE BASKET WERE REALLY PUSHED AGAINST THE MUCOSA. THERE WAS NO EMERGENCY LITHOTRIPTOR IMMEDIATELY AVAILABLE IN THE ROOM AS THE OLYMPUS TERRITORY MANAGER WAS BRINGING A SEALED AND NEW LITHOTRIPTOR FROM HOME, TOTAL TIME FOR WHICH WAS APPROXIMATELY THREE HOURS. WHEN THE LITHOTRIPTER WAS AVAILABLE, THE SHEATH COULD NOT SWIM FAR ENOUGH TO REACH THE STONE. EITHER THE PAPILLA AREA WAS PERHAPS A LITTLE BIT SWOLLEN OR OTHERWISE DEVICE CABLES WERE HARD PRESSED AGAINST THE MUCOSA, THUS PREVENTING THE SHEATH FROM REACHING THE STONE. THE STONE NEEDED TO BE BROKEN IN ORDER TO ENABLE THE DEVICE REMOVAL WITH THE BALLOON. THE STONE WAS BROKEN WITH SPYGLASS. THE BROKEN STONE WAS REMOVED FROM BILE DU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15725132 ↗
• MalfunctionSep 8, 2022Break; Break

  THE CUSTOMER REPORTED THAT, DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE, THE SHAFT ON THE SUBJECT DEVICE WAS BROKEN WHERE IT CONNECTED WITH THE MECHANICAL LITHOTRIPTOR HANDLE. THE USER DID NOT ORIGINALLY INTEND TO USE THE HANDLE BUT IT WAS USED BECAUSE THE STONE WAS LARGER THAN EXPECTED AND THERE WAS RISK OF INCARCERATION. IT WAS NOTED THAT THERE WAS NO ACTUAL INCARCERATION. THE PROCEDURE WAS COMPLETED USING THE SUBJECT DEVICE. THE SUBJECT DEVICE WAS SENT TO AN OLYMPUS SERVICE CENTER FOR EVALUATION. DURING INSPECTION AND TESTING, THE OPERATING ROD WAS BROKEN AND THE BASKET WOULD NOT OPEN OR CLOSE. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION (BASKET WOULD NOT OPEN OR CLOSE). THERE WAS NO EFFECT ON THE PATIENT DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15384589 ↗
• MalfunctionSep 7, 2022Mechanical Jam; Mechanical Jam

  THE CUSTOMER REPORTED THAT, DURING A PROCEDURE, THE RETRIEVAL BASKET COULD NOT BE INSERTED INTO THE ENDOSCOPE. A SECOND DEVICE WAS OPENED AND STONES WERE COLLECTED. WHEN ATTEMPTING TO USE THE SECOND DEVICE TO RETRIEVE ADDITIONAL STONES, IT DID NOT UNFOLD. THE USER ATTEMPTED THE FIRST DEVICE AGAIN AND WAS ABLE TO INSERT IT IN THE ENDOSCOPE BUT IT ALSO DID NOT UNFOLD. A THIRD DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE SUBJECT DEVICE WAS SENT TO OLYMPUS FOR EVALUATION. DURING INSPECTION AND TESTING, THE BASKET COULD NOT BE OPENED. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION (UNABLE TO OPEN BASKET). THERE WAS NO EFFECT ON THE PATIENT DUE TO THE EVENT. THIS REPORT IS FOR THE FIRST DEVICE. THE SECOND DEVICE IS BEING REPORTED ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15375609 ↗