Memory Basket G25149Recalls & reported problems

Summary

The FDA's MAUDE database contains 75 adverse event reports that list this exact device (DI 00827002251496), received between Jul 14, 2017 and Sep 25, 2026 — classified as 1 injury, 74 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (31 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 75 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902658 ↗
• MalfunctionAug 6, 2026Difficult to Fold, Unfold or Collapse; Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50158600 ↗
• MalfunctionJul 14, 2026Difficult to Fold, Unfold or Collapse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25814725 ↗
• MalfunctionJul 13, 2026Difficult to Fold, Unfold or Collapse; Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25795949 ↗
• MalfunctionJul 2, 2026Difficult to Fold, Unfold or Collapse

  IN PREPARATION FOR AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, THE PHYSICIAN SELECTED A COOK MEMORY II DOUBLE LUMEN EXTRACTION BASKETS. IT WAS REPORTED THAT WHEN THE NURSE TRIED TO PUT THE BASKET INSIDE THE SHEATH, THE BASKET WAS NOT PUT INSIDE [UNABLE TO RETRACT BASKET]. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25696336 ↗
• MalfunctionJun 15, 2026Difficult to Fold, Unfold or Collapse; Material Separation

  DURING STONE EXTRACTION IN THE COMMON BILE DUCT, THE PHYSICIAN SELECTED A COOK MEMORY II DOUBLE LUMEN EXTRACTION BASKET. IT WAS INITIALLY REPORTED THAT THE NURSE OPENED THE PACKAGING OF THE NEW PRODUCT AND INSPECTED THE BASKET FOR ANY ABNORMALITIES BEFORE INSERTING IT INTO THE SCOPE AND FOUND NONE. HOWEVER, WHEN THEY POSITIONED THE BASKET INSIDE THE BILE DUCT AND MANIPULATED THE HANDLE, IT DID NOT MOVE. THE BASKET ALSO DID NOT COME OUT OF THE SHEATH. THEREFORE, THEY HAD TO REMOVE THE MB-35-2X4-8 FROM THE PATIENT AND USE A NEW MB-35-2X4-8, THIS BASKET DIDN'T MOVE INSIDE THE CBD. SO THEY HAD TO USE A NEW ONE OF ANOTHER LOT NUMBER. THERE WAS NO REPORTABLE INFORMATION AT THAT TIME. THE DEVICE WAS RECEIVED ON 19MAY2026 AND DURING QE INVESTIGATION THE BASKET WOULD NOT MOVE WHEN THE HANDLE WAS MANIPULATED, THEN THE HANDLE WAS DISASSEMBLED. THE DRIVE WIRE WAS SEPARATED FROM THE HANDLE, AND NESTING WAS OBSERVED IN THE PURPLE HUB [SUBJECT OF REPORT]. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25513304 ↗
• MalfunctionJun 15, 2026Difficult to Fold, Unfold or Collapse; Material Separation

  DURING STONE EXTRACTION IN THE COMMON BILE DUCT, THE PHYSICIAN SELECTED A COOK MEMORY II DOUBLE LUMEN EXTRACTION BASKET. IT WAS INITIALLY REPORTED THAT THE OPEN/CLOSE FUNCTION ON THE HANDLE OF THIS PRODUCT DID NOT WORK. THERE WAS NO REPORTABLE INFORMATION AT THAT TIME. THE DEVICE WAS RECEIVED ON 19MAY2026 AND DURING QE INVESTIGATION THE BASKET WOULD NOT MOVE WHEN THE HANDLE WAS MANIPULATED, THEN THE HANDLE WAS DISASSEMBLED. THE DRIVE WIRE WAS SEPARATED FROM THE HANDLE, AND NESTING WAS OBSERVED IN THE PURPLE HUB [SUBJECT OF REPORT]. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25512785 ↗
• MalfunctionJun 12, 2026Loss of or Failure to Bond; Difficult to Fold, Unfold or Collapse; Nonstandard Device

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY IN THE DUODENUM, THE PHYSICIAN USED A COOK MEMORY II DOUBLE LUMEN EXTRACTION BASKET. IT WAS REPORTED THAT WHILE OPERATING THE HANDLE TO RETRIEVE A STONE INSIDE THE BILE DUCT, THE SCREW OF THE DEVICE HANDLE BECAME LOOSE. THE NURSE TIGHTENED THE SCREW AGAIN TO SECURE IT. AFTERWARDS, WHEN TRYING TO RETRACT THE BASKET BACK INTO THE SHEATH AND THEN PULLING IT OUT AGAIN, THE HANDLE WOULD NOT MOVE [UNABLE TO RETRACT BASKET - SUBJECT OF REPORT]. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25491045 ↗
• MalfunctionApr 6, 2026Difficult to Fold, Unfold or Collapse; Material Separation

  IN PREPARATION FOR AN UNSPECIFIED PROCEDURE, THE PHYSICIAN SELECTED A COOK MEMORY II DOUBLE LUMEN EXTRACTION BASKET. IT WAS INITIALLY REPORTED THAT THE HANDLE OF THE BASKET WAS FOUND TO BE BENT BEFORE THE PACKAGING WAS OPENED. THIS HAS NOT HISTORICALLY CAUSED OR CONTRIBUTED TO SERIOUS INJURY TO THE PATIENT OR USER SO THERE WAS NO REPORTABLE INFORMATION AT THAT TIME. THE DEVICE RETURNED ON 11MAR2026 AND THE DEVICE BROKE AT THE HANDLE CANNULA DURING EVALUATION. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT. IN ADDITION, THE USER SUSTAINED NO CLINICAL CONSEQUENCE AND THERE WERE NO ADVERSE EFFECTS TO THE USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24792129 ↗
• MalfunctionApr 3, 2026Difficult to Fold, Unfold or Collapse; Material Separation

  DURING STONE EXTRACTION IN THE COMMON BILE DUCT, THE PHYSICIAN SELECTED A COOK MEMORY II DOUBLE LUMEN EXTRACTION BASKET. IT WAS INITIALLY REPORTED THAT THE ASSIST NURSE MANIPULATED THE HANDLE TO UNFOLD FOR CAPTURE BILE DUCT SMALL STONES, BUT THE BASKET DID NOT COME OUT OF THE SHEATH. THIS WAS INTERPRETED AS UNABLE TO ADVANCE THE BASKET. THERE WAS NO REPORTABLE INFORMATION AT THAT TIME. THE DEVICE WAS RECEIVED ON 09MAR2026 AND DURING QE INVESTIGATION THE BASKET WOULD NOT MOVE WHEN THE HANDLE WAS MANIPULATED, THEN THE HANDLE WAS DISASSEMBLED. THE DRIVE WIRE WAS SEPARATED FROM THE HANDLE, AND NESTING WAS OBSERVED IN THE PURPLE HUB. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24781459 ↗
• MalfunctionMar 2, 2026Difficult to Fold, Unfold or Collapse; Material Separation

  DURING AND ENDOSCOPIC SPHINCTEROTOMY FOR STONE EXTRACTION IN THE COMMON BILE DUCT, THE PHYSICIAN SELECTED TWO COOK MEMORY II DOUBLE LUMEN EXTRACTION BASKETS. IT WAS INITIALLY REPORTED THAT THE ASSIST NURSE MANIPULATED THE HANDLE TO UNFOLD FOR CAPTURING BILE DUCT SMALL STONES, BUT THE HANDLE DID NOT WORK. THERE WAS NO REPORTABLE INFORMATION AT THAT TIME. THE DEVICE WAS RECEIVED ON 06FEB2026 AND THE BASKET WOULD NOT MOVE WHEN THE HANDLE WAS MANIPULATED. THE HANDLE WAS DISASSEMBLED, AND IT WAS NOTED THE DRIVE WIRE WAS DISCONNECTED FROM THE HANDLE WITH NESTING IN THE PURPLE HUB. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24483100 ↗
• MalfunctionFeb 4, 2026Difficult to Fold, Unfold or Collapse

  DURING STONE EXTRACTION IN THE COMMON BILE DUCT, THE PHYSICIAN SELECTED A COOK MEMORY II DOUBLE LUMEN EXTRACTION BASKET. IT WAS INITIALLY REPORTED THAT BEFORE USING IT ON THE PATIENT, THE OPERATION WAS CHECKED. THE HANDLE MOVED, BUT THE BASKET DID NOT MOVE. THE BASKET IS PACKAGED WITH THE BASKET EXTENDED SO THIS IS INTERPRETED AS UNABLE TO RETRACT THE BASKET. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT. IN ADDITION, THE USER SUSTAINED NO CLINICAL CONSEQUENCE AND THERE WERE NO ADVERSE EFFECTS TO THE USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24258573 ↗
• MalfunctionFeb 3, 2026Difficult to Fold, Unfold or Collapse

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, THE PHYSICIAN USED TWO COOK MEMORY II DOUBLE LUMEN EXTRACTION BASKETS. IT WAS REPORTED THAT WHEN THE NURSE TRIED TO PUT THE BASKET INSIDE THE SHEATH, THE BASKET WAS NOT PUT INSIDE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24250002 ↗
• MalfunctionFeb 3, 2026Difficult to Fold, Unfold or Collapse; Material Separation

  DURING AN ENDOSCOPIC SPHINCTEROTOMY, THE PHYSICIAN USED TWO COOK MEMORY II DOUBLE LUMEN EXTRACTION BASKETS. IT WAS INITIALLY REPORTED THAT THE ASSIST NURSE MANIPULATED THE HANDLE TO UNFOLD FOR CAPTURE BILE DUCT SMALL STONES, BUT THE HANDLE DID NOT WORK. THIS WAS INTERPRETED TO BE UNABLE TO ADVANCE THE BASKET SO THERE WAS NO REPORTABLE INFORMATION AT THAT TIME. THE DEVICES RETURNED ON 09JAN2026 AND DURING QE EVALUATION THE HANDLE WOULD MOVE ON BOTH DEVICES HOWEVER THE BASKETS WOULD NOT. BOTH HANDLES WERE DISASSEMBLED AND THE DRIVE WIRES WERE DISCONNECTED FROM THE HANDLE WITH NESTING IN THE PURPLE HUBS. [SUBJECT OF REPORT]. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24246710 ↗
• MalfunctionJan 22, 2026Difficult to Fold, Unfold or Collapse; Material Separation

  DURING AN ENDOSCOPIC SPHINCTEROTOMY, THE PHYSICIAN USED A COOK MEMORY II DOUBLE LUMEN EXTRACTION BASKET. IT WAS INITIALLY REPORTED THAT THE ASSIST NURSE MANIPULATED THE HANDLE TO UNFOLD FOR CAPTURE BILE DUCT SMALL STONES, BUT THE HANDLE DID NOT WORK. THIS WAS INTERPRETED TO BE THE BASKET UNABLE TO ADVANCE WHICH HAS NOT HISTORICALLY CAUSED OR CONTRIBUTED TO A SERIOUS INJURY NOR DEATH TO THE PATIENT, THEREFORE THERE WAS NO REPORTABLE INFORMATION AT THAT TIME. THE DEVICE WAS RECEIVED ON 20DEC2026 AND THE WIRE WAS DISCONNECTED FROM THE HANDLE WITH NESTING IN THE PURPLE HUB [SUBJECT OF REPORT]. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24149317 ↗
• MalfunctionJan 22, 2026Difficult to Fold, Unfold or Collapse; Material Separation

  DURING AN ENDOSCOPIC SPHINCTEROTOMY, THE PHYSICIAN USED A COOK MEMORY II DOUBLE LUMEN EXTRACTION BASKET. IT WAS INITIALLY REPORTED THAT THE ASSIST NURSE MANIPULATED THE HANDLE TO UNFOLD FOR CAPTURE BILE DUCT SMALL STONES, BUT THE HANDLE DID NOT WORK. THIS WAS INTERPRETED TO BE THE BASKET UNABLE TO ADVANCE WHICH HAS NOT HISTORICALLY CAUSED OR CONTRIBUTED TO A SERIOUS INJURY NOR DEATH TO THE PATIENT, THEREFORE THERE WAS NO REPORTABLE INFORMATION AT THAT TIME. THE DEVICE WAS RECEIVED ON 29DEC2025 AND THE WIRE WAS DISCONNECTED FROM THE HANDLE WITH NESTING IN THE PURPLE HUB [SUBJECT OF REPORT]. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24146109 ↗
• MalfunctionJan 5, 2026Fracture

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY FOR CBD STONE EXTRACTION, THE PHYSICIAN USED A COOK MEMORY II DOUBLE LUMEN EXTRACTION BASKET. IT WAS REPORTED THAT THE NURSE OPENED THE PACKAGING OF THE NEW PRODUCT AND INSPECTED THE BASKET FOR ANY ABNORMALITIES BEFORE INSERTING IT INTO THE SCOPE AND FOUND NONE. THEY OPENED THE BASKET INSIDE THE DUCT AND PULLED OUT SMALL STONES. HOWEVER, THE ENDOSCOPIC IMAGE SHOWED THAT ONE OF THE BASKET WIRES WAS BROKEN. THEY REMOVED THE BASKET FROM THE SCOPE AND COMPLETED THE PROCEDURE USING A NEW MB-35-2X4-8. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23962418 ↗
• MalfunctionDec 9, 2025Difficult to Fold, Unfold or Collapse; Material Separation; Difficult to Fold, Unfold or Collapse; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) FOR STONE REMOVAL IN THE BILE DUCT, THE PHYSICIAN SELECTED A COOK MEMORY II DOUBLE LUMEN EXTRACTION BASKET. IT WAS INITIALLY REPORTED THAT BEFORE INSERTION INTO THE ENDOSCOPE'S FORCEPS CHANNEL, THE BASKET COULD BE OPENED AND CLOSED. ONCE THE DEVICE WAS PLACED ALONG THE GUIDEWIRE TO APPROACH THE STONE IN THE BILE DUCT AND ATTEMPTED TO DEPLOY THE BASKET, IT FAILED TO OPEN. THERE WAS NO REPORTABLE INFORMATION AT THAT TIME. THE DEVICE WAS RETURNED ON 14NOV2025 AND EVALUATED. IT WAS OBSERVED THAT THE DEVICE THE HANDLE WOULD NOT MOVE, AND GRINDING COULD BE FELT IN THE HANDLE WHEN ATTEMPTING TO MANIPULATE THE HANDLE. THE HANDLE WAS DISASSEMBLED, AND THE DRIVE WIRE WAS FRAYED BUT ATTACHED BY A FEW WIRES THAT HAD NOT DETACHED. AFTER DECONTAMINATION THE DEVICE WAS REMOVED, AND IT WAS NOTED THAT THE HANDLE WAS THEN DISCONNECTED FROM THE DRIVE WIRE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23757399 ↗
• MalfunctionDec 5, 2025Difficult to Fold, Unfold or Collapse; Material Separation; Difficult to Fold, Unfold or Collapse; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) FOR STONE REMOVAL IN THE BILE DUCT, THE PHYSICIAN SELECTED A COOK MEMORY II DOUBLE LUMEN EXTRACTION BASKET. IT WAS REPORTED THAT UPON OPENING THE PACKAGE AND PERFORMING A FUNCTIONALITY CHECK PRIOR TO ENDOSCOPE USE (BEFORE INSERTION INTO THE BODY), THE DEVICE COMPLETELY FAILED TO OPEN OR CLOSE. THE DEVICE IS PACKAGED WITH THE BASKET EXTENDED SO THE BASKET WOULD HAVE BEEN UNABLE TO RETRACT INTO THE SHEATH. THIS OCCURRED DURING A PRODUCT DEMONSTRATION; NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23727480 ↗
• MalfunctionNov 20, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IN PREPARATION FOR A CBD STONE EXTRACTION, THE PHYSICIAN SELECTED TWO (2) COOK MEMORY II DOUBLE LUMEN EXTRACTION BASKETS. IT WAS REPORTED THAT BEFORE USING IT ON THE PATIENT, THE OPERATION WAS CHECKED. THE HANDLE DIDN'T MOVE, AND THE BASKET DID NOT MOVE. THESE DEVICES ARE PACKAGED WITH THE BASKET EXTENDED SO IF THE HANDLE WOULD NOT MOVE THEN THE BASKET WOULD NOT RETRACT (SUBJECT OF REPORT). THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23607068 ↗
• MalfunctionNov 20, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IN PREPARATION FOR A CBD STONE EXTRACTION, THE PHYSICIAN SELECTED MULTIPLE COOK MEMORY II DOUBLE LUMEN EXTRACTION BASKETS. IT WAS REPORTED THAT BEFORE USING IT ON THE PATIENT, THE OPERATION WAS CHECKED. THE HANDLE DIDN'T MOVE, AND THE BASKET DID NOT MOVE. THESE DEVICES ARE PACKAGED WITH THE BASKET EXTENDED SO IF THE HANDLE WOULD NOT MOVE THEN THE BASKET WOULD NOT RETRACT (SUBJECT OF REPORT). SIX (6) PRODUCTS HAD THE SAME DEFECT. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23606988 ↗
• MalfunctionOct 22, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IN PREPARATION FOR A CBD STONE EXTRACTION, THE PHYSICIAN SELECTED A COOK MEMORY II DOUBLE LUMEN EXTRACTION BASKET. IT WAS REPORTED THAT BEFORE USING IT ON THE PATIENT, THE OPERATION WAS CHECKED. THE HANDLE MOVED, BUT THE BASKET DID NOT MOVE. THE MB-35-2X4-8 IS PACKAGED WITH THE BASKET EXTENDED SO AS THEY REPORT THAT THE PROBLEM OCCURRED BEFORE USING IT ON THE PATIENT WHILE TESTING DEVICE FUNCTION, THE BASKET WOULD BE EXTENDED WHEN THE HANDLE WOULD MOVE BUT THE BASKET WOULD NOT. THIS IS THEREFORE BEING INTERPRETED AS UNABLE TO RETRACT THE BASKET. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23361172 ↗
• MalfunctionOct 22, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IN PREPARATION FOR A CBD STONE EXTRACTION, THE PHYSICIAN SELECTED A COOK MEMORY II DOUBLE LUMEN EXTRACTION BASKET. IT WAS REPORTED THAT BEFORE USING IT ON THE PATIENT, THE OPERATION WAS CHECKED. THE HANDLE MOVED, BUT THE BASKET DID NOT MOVE. THE MB-35-2X4-8 IS PACKAGED WITH THE BASKET EXTENDED SO AS THEY REPORT THAT THE PROBLEM OCCURRED BEFORE USING IT ON THE PATIENT WHILE TESTING DEVICE FUNCTION, THE BASKET WOULD BE EXTENDED WHEN THE HANDLE WOULD MOVE BUT THE BASKET WOULD NOT. THIS IS THEREFORE BEING INTERPRETED AS UNABLE TO RETRACT THE BASKET. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23361106 ↗
• MalfunctionSep 3, 2025Difficult to Fold, Unfold or Collapse; Material Separation; Difficult to Fold, Unfold or Collapse; Material Separation

  DURING A BILE DUCT STONE REMOVAL, THE PHYSICIAN USED A COOK MEMORY II DOUBLE LUMEN EXTRACTION BASKET. IT WAS INITIALLY REPORTED THAT AN ATTEMPT WAS MADE TO OPEN THE BASKET INSIDE THE BILE DUCT, BUT THE HANDLE DID NOT MOVE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE (DETAIL UNKNOWN). THERE WAS NO REPORTABLE INFORMATION AT THAT TIME. THE DEVICE WAS RECEIVED FOR EVALUATION ON 12AUG2025 AND THE DRIVE WIRE WAS BROKEN FROM THE HANDLE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22954780 ↗
• MalfunctionAug 29, 2025Difficult to Fold, Unfold or Collapse; Material Separation; Difficult to Fold, Unfold or Collapse; Material Separation

  DURING STONE RETRIEVAL, THE PHYSICIAN USED A COOK MEMORY II DOUBLE LUMEN EXTRACTION BASKET. IT WAS INITIALLY REPORTED THAT DURING THE SECOND RETRIEVAL ATTEMPT; THE DEVICE BECAME STUCK [INTERPRETED AS UNABLE TO ADVANCE THE BASKET]. THE ENTIRE ASSEMBLY WAS WITHDRAWN, AND A NEW SET WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTABLE INFORMATION AT THAT TIME. THE DEVICE WAS RECEIVED FOR EVALUATION ON 05 AUG 2025 AND THE HANDLE WAS BROKEN AND THE DRIVE WIRE WAS SEPARATED FROM THE HANDLE (SUBJECT OF REPORT). A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22922055 ↗