Cook G15054Recalls & reported problems
Cook Incorporated · Cup Biopsy Forceps · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00827002150546), received between Feb 24, 2020 and Oct 21, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Separation” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Separation3
Patient problems
- Device Embedded In Tissue or Plaque1
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 21, 2024Material Separation; Material Separation
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20498916 ↗MalfunctionFeb 24, 2020Material Separation; Material Separation
IT WAS REPORTED, DURING A URETEROSCOPY WITH BIOPSY IN THE URETER/COLLECTING SYSTEM THAT TWO CUP BIOPSY FORCEPS WERE USED. BOTH DEVICES BROKE IN HALF AT THE CUP PORTION. THE BROKEN PIECE FROM ONE OF THE DEVICES WAS ABLE TO BE RETRIEVED, BUT THE BROKEN PIECE FROM THE OTHER DEVICE WAS NOT ABLE TO BE RETRIEVED AND WAS LEFT IN THE PATIENT. THIS REPORT WILL BE FOR THE DEVICE WHERE THEY WERE UNABLE TO RETRIEVE THE BROKEN PIECE. REFERENCE PATIENT IDENTIFIER (B)(6) FOR THE DEVICE WHERE THEY WERE ABLE TO RETRIEVE THE BROKEN PIECE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE PATIENT AND THE EVENT. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 9746186 ↗MalfunctionFeb 24, 2020Material Separation; Material Separation
NO ADDITIONAL PATIENT OR EVENT INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9746152 ↗
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- n.a. 27071TJKarl Storz GmbH & Co. KG · Endoscopic grasping/cutting instrument, non-powered6 reports
- Raptor 00711178US Endoscopy · Endoscopic grasping/cutting instrument, non-powered5 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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