CONMED 9704Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10845854019320), received between Feb 1, 2022 and Sep 28, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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.

• MalfunctionSep 28, 2023Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THAT THE 9704, 5.5MM (I.D.) X 70MM UNIVERSAL CAN SET WITH FENES WAS BEING USED DURING AN ARTHROSCOPIC ROTATOR CUFF PROCEDURE ON (B)(6) 2023 DATE WHEN IT WAS REPORTED ¿THE SURGEON WAS COMPLAINING THAT THE 9704 CANNULA SEEMED TIGHTER WHEN INSERTING THE TROCAR AND SHAVER HANDPIECE. DURING TISSUE RESECTION, HE NOTICED THAT A PIECE OF PLASTIC INSIDE THE SHOULDER, WHICH HE WAS ABLE TO REMOVE. THE PLASTIC WAS FROM THE SEAL IN THE CANNULA. I TESTED ANOTHER CANNULA WITH THE SAME LOT NUMBER AND IT TOO FELT TIGHT SO WE WILL BE SENDING THE ENTIRE BOX BACK WITH THE USED, BROKEN CANNULA.¿ IT W AS ALSO REPORTED THAT THE ¿SURGERY COMPLETED AFTER PLASTIC WAS REMOVED.¿ AS WELL AS THE SAME ALTERNATE DEVICE WAS USED, AND A TWO-MINUTE DELAY WAS REPORTED IN THE PROCEDURE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17833343 ↗
• MalfunctionFeb 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ON BEHALF OF THE CUSTOMER, THE CONMED REPRESENTATIVE REPORTED ISSUES WITH THE 5.5MM X 70MM UNIVERSAL CANNULA SET W/ FENESTRATIONS # 9704, LOT 1145879 RECENTLY EXPERIENCED BY (B)(6) ON (B)(6) 2022. IT WAS REPORTED THAT ¿THE SEAL KEEPS COMING OUT WHEN REMOVING THE INSTRUMENTATION FROM THE CANNULA. NO DELAY, NO INJURY, JUST NEEDING TO REPLACE FREQUENTLY. IT DOESN'T HAPPEN WITH EVERY CANNULA BUT WITH QUITE A FEW.¿ IT IS NOTED THERE WAS NO IMPACT OR INJURY TO THE PATIENT. DESPITE MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION, NO CLARIFICATION OR INCIDENT DETAILS HAVE BEEN RECEIVED FROM THE REPORTER. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE AS IT WAS REPORTED THE SEAL DETACHED DURING SURGERY WHILE REMOVING INSTRUMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13415414 ↗