The Web G22776Recalls & reported problems
Cook Incorporated · The Web Extraction Basket · Class 2
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00827002227767), received between Feb 19, 2016 and Feb 20, 2025 — classified as 2 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Fracture” (3 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.
Reports received per month
Most reported problems
Device problems
- Fracture3
- Difficult to Remove1
- Material Deformation1
- Material Split, Cut or Torn1
- Mechanical Jam1
Patient problems
- No Consequences Or Impact To Patient3
- Device Embedded In Tissue or Plaque1
- Foreign Body In Patient1
- No Patient Involvement1
- Obstruction/Occlusion1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryFeb 20, 2025Difficult to Remove; Difficult to Remove
DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, ERCP, THE PHYSICIAN USED A COOK WEB EXTRACTION BASKET. IT WAS REPORTED THAT THE BASKET BECAME IMPACTED IN THE BATTERY AMPOULE [DUCT/PAPILLA]. ALL POSSIBLE MANEUVERS WERE PERFORMED TO REMOVE IT BUT IT WAS NOT POSSIBLE, THEREFORE THE PATIENT WAS TAKEN TO SURGERY. THE BASKET WAS RECOVERED BY SURGERY (EXPLORATORY LAPAROTOMY). ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 21425474 ↗InjuryAug 23, 2019Fracture; Mechanical Jam; Fracture; Mechanical Jam
DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED TWO (2) COOK THE WEB EXTRACTION BASKETS. THE ERCP WITH WIDE PAPILLOTOMY WAS PERFORMED, SHOWING THE OUTFLOW OF PURULENT MATERIAL. CHOLANGIOPANCREATOGRAPHY DEMONSTRATED COMPACTED CALCULUS IN THE DISTAL THIRD OF THE BILE DUCT. THEY PASSED THE EXTRACTOR BASKET, WITH IMPACTION OF THIS (SIC). THE USER ATTEMPTED LITHOTRIPSY WITH LITHOTRIPTER, WITH EXTRACTOR BASKET BREAKING. A NEW BASKET WAS USED AND IT BROKE IN THE BILIARY TRACT. AFTER NUMEROUS ATTEMPTS TO WITHDRAW, WE DECIDED TO SUSPEND THE PROCEDURE AND INDICATE EMERGENCY LAPAROTOMY. THE BROKEN BASKET REMAINED INSIDE THE PATIENT¿S BODY. THE PATIENT WAS TAKEN TO SURGERY FOR AN EMERGENCY LAPAROTOMY TO HAVE THE BASKET REMOVED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: Foreign Body In Patient; Obstruction/Occlusion
MAUDE report 8928096 ↗MalfunctionJul 26, 2019Material Split, Cut or Torn; Material Split, Cut or Torn
DURING A STONE REMOVAL PROCEDURE, THE PHYSICIAN USED A COOK WEB II MEMORY EXTRACTION BASKET. AFTER SEVERAL PASSES, THE BASKET BECAME DIFFICULT TO CLOSE. THE NURSE USED FORCE TO CLOSE THE BASKET, [AND] WHERE [SIC] ONE OF THE WIRES APPEARED TO COME THOUGH THE CATHETER [SHEATH]. NO CONTRAST COULD BE USED AS HOLE PRESENTED IN LUMEN OF THE DEVICE CATHETER [DRIVE WIRE COMES THROUGH SHEATH]. 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 Consequences Or Impact To Patient
MAUDE report 8833724 ↗MalfunctionJun 4, 2019Fracture; Fracture
AFTER A LITHOTRIPSY PROCEDURE, THE PHYSICIAN TESTED ONE (1) PRIOR TO USE COOK WEB EXTRACTION BASKET. THE WIRE OF THE BASKET TORE CLOSE TO HANDLE WHILE DOING AN EMERGENCY LITHOTRIPSY [SEE RELATED EMDR 1037905-2019-00304]. THE STONE CAME OUT OF THE BASKET. AFTER THE PROCEDURE, THE USERS TRIED TO REPLICATE THE MALFUNCTION ON A DEVICE OF THE SAME LOT NUMBER OUTSIDE THE PATIENT WITH THE SAME RESULT. WHEN COOK SALES REPRESENTATIVE WAS THERE TO COLLECT THE DEVICES FOR RETURN, A FURTHER CHECK (OUTSIDE PATIENT) WAS TRIED WITH ANOTHER BASKET WITH SAME LOT NUMBER. THE WIRES TORE AS WELL [ALSO RELATED EMDR 1037905-2019-00304]. THEY CHECKED WITH SAME PRODUCT OF ANOTHER LOT NUMBER, BUT AS WELL THE WIRES TORE [SUBJECT OF THIS REPORT]. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Patient Involvement
MAUDE report 8667653 ↗MalfunctionJun 4, 2019Fracture; Fracture
DURING A LITHOTRIPSY PROCEDURE, THE PHYSICIAN USED ONE (1) AND TESTED TWO (2) PRIOR TO USE COOK WEB EXTRACTION BASKETS. THE WIRE OF THE BASKET TORE CLOSE TO HANDLE WHILE DOING AN EMERGENCY LITHOTRIPSY [SUBJECT OF THIS REPORT]. THE STONE CAME OUT OF THE BASKET. AFTER THE PROCEDURE, THE USERS TRIED TO REPLICATE THE MALFUNCTION ON A DEVICE OF THE SAME LOT NUMBER OUTSIDE THE PATIENT WITH THE SAME RESULT. WHEN COOK SALES REPRESENTATIVE WAS THERE TO COLLECT THE DEVICES FOR RETURN, A FURTHER CHECK (OUTSIDE PATIENT) WAS TRIED WITH ANOTHER BASKET WITH SAME LOT NUMBER. THE WIRES TORE AS WELL [ALSO SUBJECT OF THIS REPORT]. THEY CHECKED WITH SAME PRODUCT OF ANOTHER LOT NUMBER, BUT AS WELL THE WIRES TORE [SEE RELATED EMDR 1037905-2019-00305]. 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 Consequences Or Impact To Patient
MAUDE report 8667618 ↗MalfunctionFeb 19, 2016Material Deformation; Material Deformation
DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON A PATIENT OF UNKNOWN AGE AND GENDER, THE PHYSICIAN USED A COOK THE WEB EXTRACTION BASKET. THE PLASTIC SHEATH SEPARATED FROM THE WIRES WHILE CRANKING DOWN ON THE SOHENDRA LITHOTRIPTER. THE PHYSICIAN REMOVED [THE DEVICE] WITH NO HARM TO THE PATIENT AND WAS ABLE TO USE ANOTHER OF THE SAME DEVICE TO COMPLETE THE PROCEDURE. THE COOK REPRESENTATIVE PROVIDED THE FOLLOWING CLARIFICATION ON (B)(6) 2016: WHILE CRANKING DOWN ON THE HANDLE OR LITHOTRIPSY CRANK, THE PLASTIC SHEATH SEPARATED I.E. CUT AND DUG INTO THE LITHOTRIPSY WIRE. THE CUSTOMER CUT THE PLASTIC FROM THE HANDLE WHICH WAS NOT WHERE THE PROBLEM WAS. THE PROBLEM WAS THAT THE DISTAL END WHERE THE BASKET WAS TRYING TO CRUSH THE STONE. IT [THE BASKET] HAD CUT INTO THE PLASTIC AT THE DISTAL END.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5447138 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.