Ring-McLean G07768Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002077683), received between Nov 30, 2017 and Aug 15, 2018 — classified as 2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 15, 2018Break; Entrapment of Device

  IT WAS REPORTED THAT IN TWO OF THE ULTRATHANE RING-MCLEAN COOK-COPE TYPE LOCKING LOOP SUMP DRAINAGE SETS, THE WIRES BECAME STUCK AND BROKEN WITHIN THE DRAIN DURING AN ABSCESS DRAINAGE PROCEDURE. NO INJURIES OR ADDITIONAL PROCEDURES WERE REPORTED, AND NO PIECES OF THE WIRES WERE LEFT IN THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7784812 ↗
• MalfunctionNov 30, 2017Break; Material Frayed; Break; Material Frayed

  THE INTERNATIONAL CUSTOMER EMPLOYING AN ULTRATHANE RING-MCLEAN COOK-COPE TYPE LOCKING LOOP SUMP DRAINAGE SET REPORTED THAT, DURING THE FITTING OF THE DRAINAGE PROBE, WHEN THE GUIDE WAS RETRIEVED, IT BECAME SHREDDED. A PIECE OF THE GUIDE REMAINED IN THE PROBE. A "SCANNER CHECK" [SIC] WAS PERFORMED AFTER. THE CUSTOMER CONFIRMED THAT NO PATIENT ADVERSE EVENTS OCCURRED, AND NO ADDITIONAL PROCEDURES WERE NECESSITATED AS A RESULT OF THE PRODUCT ISSUE. THE DEVICE IS REPORTEDLY AVAILABLE FOR RETURN; HOWEVER, AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION. NO FURTHER INFORMATION WAS AVAILABLE FROM THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7072957 ↗