FMS 282112Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886705020478), received between Aug 9, 2018 and Apr 25, 2024 — classified as 5 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. 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.

• MalfunctionApr 25, 2024Use of Device Problem; Blocked Connection; Suction Failure; Use of Device Problem; Blocked Connection; Suction Failure

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE FMS CONNECT (DUO/SOLO) DEVICE CABLE NOT SYNCHING WITH SHAVER; TRIED A DIFFERENT SHAVER AND CABLE STILL NOT WORKING. SWAPPED CABLE. DURING AN IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD A SUCTION FAILURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19179977 ↗
• MalfunctionDec 7, 2023Device Remains Activated; Output Problem; Unintended Movement; Device Remains Activated; Output Problem; Unintended Movement

  IT WAS REPORTED BY SALES REP THAT ON 10/13/2023, IT WAS OBSERVED THAT TWO (2) FMS CONNECT INTERFACE CABLE DUO/SOLO WERE HAVING ISSUES. ONE INTERFACE CABLE WOULD CONTINUE TO RUN EVEN WHEN NOT ACTIVATED AND THE OTHER ONE SEEMED LOOSE ON THE BACK OF THE HANDPIECE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD INTERMITTENT OPERATION. THE ISSUE WAS FOUND OUTSIDE OF THE PROCEDURE. NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18282766 ↗
• MalfunctionAug 1, 2022Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE FMS CONNECT INTERFACE CABLE DUO/SOLO DEVICE BROKE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15139201 ↗
• MalfunctionDec 18, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A REVISION OF EQUIPMENT, IT WAS FOUND THAT THE FMS CONNECT INTERFACE CABLE DUO/SOLO WAS BROKEN AND NO LONGER WORKED. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 9490801 ↗
• MalfunctionAug 9, 2018Intermittent Communication Failure; Intermittent Communication Failure

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR, IT WAS OBSERVED THAT HIS FMS CONNECT DUO/SOLO (UIC) WAS NOT COMMUNICATING CONSISTENTLY WITH THE PUMP. THE SALES REP REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE BY UNPLUGGING AND RESETTING THE DEVICE NUMEROUS TIMES. THE SALES REP CONFIRMED THAT THERE WERE NO PATIENT CONSEQUENCES BUT THERE WAS A FIVE MINUTE DELAY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7767194 ↗