10K 10K150Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10845854041215), received between Feb 11, 2020 and Feb 25, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Particulates” (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.

• MalfunctionFeb 25, 2020Particulates; Particulates

  THE CUSTOMER REPORTED THAT THE 10K150 ARTHROSCOPY TUBING SET WAS USED ON (B)(6) 2020 DURING A LAPAROSCOPY PROCEDURE. DURING FLUSHING THE ABDOMEN THE DOCTOR SAW THERE WERE PLASTIC PARTS INTO THE TUBE AND THEY WENT INTO THE ABDOMEN. THE PARTS WERE REMOVED UNDER A BIG EFFORT. PACKAGING WAS OK PRIOR TO PROCEDURE. PATIENT IS O.K. THIS REPORT IS BEING RAISED BASED ON DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9750362 ↗
• MalfunctionFeb 11, 2020Particulates; Particulates

  CONMED (B)(4) REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE 10K150, LINVATEC ARTHROSCOPY TUBING SET, WAS USED FOR AN ARTHROSCOPIC PROCEDURE ON (B)(6) 2020. A FOREIGN MATERIAL WAS FOUND IN THE TUBING POST OPERATIVELY. AT THIS TIME, NO DETERMINATION HAS BEEN MADE AS TO WHAT THE MATERIAL IS, BUT AN INVESTIGATION IS UNDERWAY. THERE IS NO REPORTED PATIENT INJURY OR IMPACT. THERE HAS BEEN NO REPORTED DELAY OF PROCEDURE. THE PROCEDURE WAS COMPLETED AS PLANNED. THIS REPORT IS BEING RAISED BASED ON DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY DUE TO THE UNKNOWN DEBRIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9693857 ↗