10K/24K 10K100Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10845854041208), received between Feb 3, 2020 and Jun 20, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Particulates” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2022Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, 10K100, LINVATEC 10K100 ARTHR.TUBE SET WAS BEING USED ON (B)(6) 2022 AND " DURING A LAPAROSCOPIC SURGERY, WHILE A SURGEON WAS DOING IRRIGATION, A WHITE DEBRIS WAS FOUND. IT WAS REMOVED FROM A PATIENT'S BODY AND ALSO THERE WAS NO IMPACTS ON THE PATIENT. THIS 10K100 WAS DISPOSED OF AT THE HOSPITAL.¿ THERE WAS NO IMPACT OR INJURY TO THE PATIENT OR USER. THERE WAS NO REPORT OF MEDICAL INTERVENTION OR ANY PROLONGED HOSPITALIZATION FOR THE PATIENT. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE SAME DEVICE WITH A 2 MINUTE DELAY. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14747451 ↗
• MalfunctionJun 20, 2022Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, 10K100, LINVATEC 10K100 ARTHR.TUBE SET WAS BEING USED ON 2022 AND " DURING A LAPAROSCOPIC SURGERY, WHILE A SURGEON WAS DOING IRRIGATION, A WHITE DEBRIS WAS FOUND. IT WAS REMOVED FROM A PATIENT'S BODY AND ALSO THERE WAS NO IMPACTS ON THE PATIENT. THIS 10K100 WAS DISPOSED OF AT THE HOSPITAL.¿ THERE WAS NO IMPACT OR INJURY TO THE PATIENT OR USER. THERE WAS NO REPORT OF MEDICAL INTERVENTION OR ANY PROLONGED HOSPITALIZATION FOR THE PATIENT. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE SAME DEVICE WITH A 2 MINUTE DELAY. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14747369 ↗
• MalfunctionFeb 11, 2020Particulates; Particulates

  CONMED KOREA REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE 10K100, 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 9693855 ↗
• MalfunctionFeb 11, 2020Particulates; Particulates

  CONMED (B)(4) REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE 10K100, 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 9693854 ↗
• MalfunctionFeb 3, 2020Particulates; Particulates

  CONMED (B)(4) REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE 10K100, LINVATEC ARTHROSCOPY TUBING SET, WAS USED FOR AN ARTHROSCOPIC PROCEDURE ON (B)(6) 2020. A FOREIGN MATERIAL WAS FOUND INSIDE THE CASSETTE POST OP. IT COULD ALSO BE VISIBLE ON THE BACK TABLE IN THE SALINE SOLUTION. 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, AS THIS WAS FOUND POST PROCEDURE. THIS REPORT IS BEING RAISED AS DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9660324 ↗