Cook G03298Recalls & reported problems
Cook Incorporated · Nathanson Transcystic Bile Duct Stone Exploration Pack · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002032989), received between Dec 14, 2017 and Jan 12, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (2 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
- Break2
- Device Contaminated During Manufacture or Shipping1
- Difficult to Open or Close1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 12, 2026Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THE SEALED PACKAGING OF A NATHANSON CYSTIC/COMMON BILE DUCT EXPORTATION SET CONTAINED UNKNOWN FOREIGN MATTER. THE PRODUCT WAS NOT USED. NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES WERE REPORTED FOR THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24044678 ↗MalfunctionNov 21, 2025Break; Material Separation; Break; Material Separation
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23618977 ↗MalfunctionDec 14, 2017Break; Difficult to Open or Close
DURING A LAPAROSCOPIC COMMON BILE DUCT EXPLORATION AND STONE REMOVAL PROCEDURE, THE SURGEON EXPERIENCED DIFFICULTY OPENING BASKET AFTER PASSING CATHETER THROUGH THE CLAMP. THE CATHETER AND BASKET WERE REMOVED AND THE BASKET WIRE BROKE. NO PART OF THE DEVICE REMAINED INSIDE THE PATIENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7117792 ↗
Other DISLODGER, STONE, BILIARY devices
- Memory Basket G25149Cook Incorporated · DISLODGER, STONE, BILIARY75 reports
- Stonetome M00535110Boston Scientific Corporation · DISLODGER, STONE, BILIARY74 reports
- Stonetome M00535150Boston Scientific Corporation · DISLODGER, STONE, BILIARY67 reports
- Cook G36250Cook Incorporated · DISLODGER, STONE, BILIARY1 recall10 reports
- NCompass G36251Cook Incorporated · DISLODGER, STONE, BILIARY1 recall8 reports
- Strange G09108Cook Incorporated · DISLODGER, STONE, BILIARY1 recall1 report
- Single Use Retrieval Nitinol Basket V FG-V451POlympus Medical Systems Corp. · DISLODGER, STONE, BILIARY31 reports
- SpyGlass™ Retrieval Basket M00546550Boston Scientific Corporation · DISLODGER, STONE, BILIARY23 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.