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Memory G57271Recalls & reported problems

Cook Incorporated · Memory Soft Wire Basket · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002572713), received between Jun 11, 2021 and Jun 11, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Material Split, Cut or Torn1

Patient problems

  • Foreign Body In Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 11, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) , THE PHYSICIAN USED A MEMORY SOFT WIRE BASKET. DURING THE PROCEDURE, A STONE IN THE BILE DUCT NEEDED TO BE LITHOTRIPTER. THE HANDLE OF THE MSB-2X4-D WAS CUT OFF AND THE SHEATH WAS REMOVED. WIRES WERE PULLED INTO THE COOK TTCL-10 (LITHOTRIPTOR CABLE) AND WERE CLAMPED ONTO TO THE SLH-1(SOEHENDRA LITHOTRIPTOR HANDLE). TTCL-10 WAS CONNECTED TO THE SLH-1 VIA LUERLOCK CONNECTION. THE ASSISTANT BEGAN TO CRACK THE STONE WITH SINGLE AND SHORT TURNS OF THE SLH-1. AFTER EVERY TURNING MOVEMENT SHE WAITED A SECOND AND MADE THE NEXT. AFTER A WHILE, THE WIRE OF THE MSB CRACKED INSTEAD OF THE STONE. THE BASKET WAS STILL IN PLACE AND COULD NOT BE RETRIEVED BY THE ENDOSCOPIC DEPARTMENT. PATIENT WAS BROUGHT INTO THE OR THEATRE AND BASKET WAS REMOVED VIA SURGERY. CLARIFICATION WAS RECEIVED THAT THE WIRES DID NOT RIP AT THE TIP OR AT THE HANDLE. THEY RIPPED INSIDE OF THE CONQUEST TTCL-10 [BASKET DRIVE WIRES IN THE TTCL]. IT WAS ALSO REPORTED THAT THE SURGERY WAS NOT PLANNED [AS PART OF THE ORIGINAL TREATMENT]. THE PATIENT IS (B)(6) YEARS OLD. HER GENERAL CONSTITUTION IS BEYOND LOWER LIMITS. THE SURGERY HAS NOT BEEN A POSITIVE EFFECT ON TH

    Patient problems: Foreign Body In Patient

    MAUDE report 11982037 ↗

Other DISLODGER, STONE, BILIARY devices

All DISLODGER, STONE, BILIARY devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.