FMS 284176Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10886705017256), received between May 11, 2018 and Mar 9, 2023 — classified as 1 injury, 32 malfunctions.

The most frequently reported specific device problem is “Break” (7 reports).

2 other recalls cover devices cleared under the same FDA submission (K954465); they may or may not involve this specific model.

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 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2023Break; Mechanical Problem; Use of Device Problem; Physical Resistance/Sticking; Break; Mechanical Problem; Use of Device Problem; Physical Resistance/Sticking

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN AUSTRALIA THAT THE 4 WAY FOOT PEDAL FOR FMS DUO+ HAD A FAULTY FORWARD PEDAL AND THE PIN WAS MISSING ON THE REVERSE PEDAL. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD A BROKEN AXIS ON THE REVERSE PEDAL. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16516026 ↗
• MalfunctionMar 9, 2023Output Problem; Output Problem

  IT WAS REPORTED BY THE AFFILIATE IN ITALY THAT PREOPERATIVELY TO AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE 4 WAY FOOT PEDAL FOR FMS DUO+ DEVICE WAS BROKEN. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD AN INTERMITTENT OPERATION. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. 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 16513197 ↗
• MalfunctionFeb 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN PORTUGAL THAT THE REVERSE PEDAL AND LAVAGE PEDAL FELL APART ON THE 4 WAY FOOT PEDAL FOR FMS DUO+ DEVICE. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16455679 ↗
• MalfunctionNov 24, 2022Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED BY THE AFFILIATE IN ITALY THAT PREOPERATIVELY TO AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE 4 WAY FOOT PEDAL FOR FMS DUO+ DEVICE WAS BROKEN. 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 15860882 ↗
• MalfunctionNov 18, 2022Material Frayed; Output Problem; Material Frayed; Output Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN FRANCE THAT DURING THE ELECTRICAL CABLES ON THE BASE OF THE 4 WAY FOOT PEDAL FOR FMS DUO+ DEVICE WERE FRAYED (UNCOVERED). IT WAS FURTHER REPORTED THAT THE DEVICE STOPPED WORKING FOR 30 MINUTES WHILE IN USE WITH A PUMP DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15829533 ↗
• MalfunctionNov 2, 2022Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED BY THE AFFILIATE IN ITALY THAT PREOPERATIVELY TO AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE 4 WAY FOOT PEDAL FOR FMS DUO+ DEVICE WAS BROKEN. 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 15716328 ↗
• MalfunctionAug 4, 2022Device Contaminated During Manufacture or Shipping; Appropriate Device Problem Term/Code Not Available; Device Contaminated During Manufacture or Shipping; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE SALES REP IN FRANCE THAT THE 4 WAY FOOT PEDAL FOR FMS DUO+ HAD AN UNSPECIFIED MALFUNCTION. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD DIRTY MAGNETS AND THAT THERE WAS NO DETECTION OF THE ACTION ON THE PEDAL. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15164138 ↗
• MalfunctionAug 3, 2022Device Contamination with Chemical or Other Material; Appropriate Device Problem Term/Code Not Available; Device Contamination with Chemical or Other Material; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE SALES REP IN FRANCE THAT THE 4 WAY FOOT PEDAL FOR FMS DUO+ DEVICE HAD AN UNSPECIFIED MALFUNCTION. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD DIRTY MAGNETS. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15156539 ↗
• MalfunctionMay 23, 2022Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT THE 4176 FOOT PED BOARD 4WAY FOOTSWITCH DEVICE DID NOT WORK. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE WAS BROKEN. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14476633 ↗
• MalfunctionOct 25, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT THE 4176 FOOT PED BOARD 4WAY DEVICE WAS NOT WORKING. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE PEDAL MECHANISMS WERE BROKEN. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12688674 ↗
• MalfunctionOct 13, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT PREOPERATIVELY TO AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE 4176 FOOT PED BOARD 4WAY DEVICE HAD A DEFECTIVE CONNECTOR. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD A BROKEN CONNECTOR. 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 12624620 ↗
• MalfunctionAug 18, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE CUSTOMER IN FRANCE THAT THE FOOT PED BOARD 4WAY DEVICE HAD AN UNSPECIFIED MALFUNCTION. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE SUB'D COVER WAS OXIDIZED, PEDAL MECHANISMS WERE RUSTED AND THE "FORWARD" & "REVERSE" (BLACK), "CANNULA SUCTION" (BLUE) AND "LAVAGE" (RED) COVERS WERE DETERIORATING. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THAT THE DEVICE NEEDS TO SENT FOR REPAIR. NO MORE INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12336569 ↗
• MalfunctionJul 6, 2021Use of Device Problem; Use of Device Problem

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT PREOPERATIVELY TO AN UNKNOWN PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE FOOT PED BOARD 4WAY DEVICE DID NOT WORK. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE PEDAL MECHANISM WAS CORRODED. 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 12120817 ↗
• MalfunctionJun 24, 2021Mechanical Problem; Use of Device Problem; Mechanical Problem; Use of Device Problem

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE 4176 FOOT PED BOARD 4WAY DEVICE WOULD DISENGAGE AND ITS PLASTIC COVERS WERE BROKEN. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE PEDAL MECHANISMS WERE BROKEN. 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 12059167 ↗
• MalfunctionMar 31, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT THE CANULA AND SUCTION FUNCTION OF A FOOTSWITCH DEVICE DID NOT WORK. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11597531 ↗
• MalfunctionFeb 18, 2021Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT PREOPERATIVELY TO AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE CANNULA SUCTION ON THE 4176 FOOT PED BOARD 4WAY DEVICE WAS BROKEN. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11344197 ↗
• MalfunctionDec 21, 2020Electrical /Electronic Property Problem; Unintended Movement; Electrical /Electronic Property Problem; Unintended Movement

  IT WAS REPORTED FROM THE AFFILIATE IN FRANCE THAT THE 4176 FOOT PED BOARD 4WAY DEVICE HAD A LOOSE ELECTRICAL CONNECTION. NO ADDITIONAL INFORMATION IS AVAILABLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11050802 ↗
• MalfunctionAug 25, 2020Break; Break

  IT WAS REPORTED BY THE AFFILIATE THAT THE 4176 FOOT PED BOARD 4WAY DOES NOT WORK. THERE WERE NO CONSEQUENCE FOR THE PATIENT. THE CUSTOMER STATES THAT THEY HAVE NO FURTHER INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10448436 ↗
• MalfunctionJun 30, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, A 4 WAY FOOT PEDAL WAS CUTTING IN AND OUT WHEN ACTIVATED. THEY HAD TO CHANGE OVER TO THE SECOND FOOT PEDAL TO COMPLETE PROCEDURE. NO SURGICAL DELAY OR PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10211881 ↗
• MalfunctionApr 27, 2020Intermittent Continuity; Intermittent Continuity

  IT WAS REPORTED BY AFFILIATE VIA MAIL THAT DURING SHOULDER SCOPE; 4176 FOOT PED BOARD 4WAY IS NOT WORKING. ACCOUNT BELIEVES THE PRONGS ON THE PUMP AND FOOT PEDAL MIGHT BE DAMAGED AND WORK INTERMITTENTLY. FOOT PEDAL WOULD WORK ON AND OFF BUT WAS ABLE TO COMPLETE CASE. ACTION TAKEN TO MANAGE THE ISSUE: ACCOUNT HAS OTHER PUMPS THEY CAN USE BUT HAS REQUESTED REPLACEMENT FOOT PEDAL AND PUMP BE SENT IN TO REPLACE. NO AE TO PATIENT. NO DELAY TO THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10001023 ↗
• MalfunctionMar 4, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY AFFILIATE VIA EMAIL THAT DURING SHOULDER ARTHROSCOPY THE 4176 FOOT PED BOARD 4WAY LEFT BLACK PEDAL HAS DISLOCATED FROM THE PEDAL CONSTRUCT. THE PROCEDURE WAS COMPLETED WITH SAME DEVICE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICE WAS DISCARDED AND IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9788911 ↗
• MalfunctionFeb 12, 2020Intermittent Continuity; Intermittent Continuity

  IT WAS REPORTED BY THE AFFILIATE BY CUSTOMER'S EMAIL THAT DURING AN UNKNOWN PROCEDURE THE 4176 FOOT PED BOARD 4WAY STOPPED AND IT DIDN¿T WORKED ANYMORE. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9701650 ↗
• MalfunctionDec 5, 2019Intermittent Continuity; Intermittent Continuity

  IT WAS REPORTED BY THE AFFILIATE VIA MAIL THAT DURING AN UNKNOWN PROCEDURE THE FOOT PEDAL BOARD HAD AN INTERMITTENT FAILURE. REPAIR QUOTATION APPROVAL NEEDED BEFORE REPAIR. NO PATIENT CONSEQUENCE OR SURGICAL DELAY REPORTED. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED THE ALLEGED FAILURE OF THE INSTRUMENT WAS INTERMITTENT LAVAGE FAILURE DURING THE PROCEDURE. IT WAS REPORTED A SURGICAL DELAY DID NOT OCCUR AND THE CASE WAS COMPLETED WITH THE SAME DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9418384 ↗
• InjurySep 16, 2019Intermittent Loss of Power; Intermittent Energy Output; Intermittent Loss of Power; Intermittent Energy Output

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) VIA EMAIL THAT DURING A SHOULDER ARTHROSCOPY WITH CUFF SUTURE PROCEDURE, IT WAS OBSERVED THAT THE SHAVER WORKED ALONE DURING THE SURGERY. ACCORDING TO THE REPORT, THE SALES REP THOUGHT THE PROBLEM WAS IN THE HANDPIECE AND SHE MADE THE EXCHANGE. HOWEVER, THE PROBLEM REMAINED DURING THE SURGERY. IN ADDITION, SHE REALIZED THAT THE DEVICE WORKED ONLY WHEN IT WAS PLACED ON THE PATIENT, SHE IDENTIFIED SEVERAL TIMES THE DOCTOR USING THE SHAVER WITHOUT HAVING TO STEP ON THE PEDAL. THE VAPR ALSO HAD A PROBLEM, IN THE MIDDLE OF THE SURGERY IT STOPPED WORKING, TURNED IT OFF AND TURNED IT ON AND THE PRODUCT CONTINUED TO PRESENT A PROBLEM. CONSEQUENCE: THE DOCTOR CHOSE TO END THE OPEN SURGERY. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. THIS COMPLAINT INVOLVES TWO (2) DEVICES.

  Patient problems: No Code Available

  MAUDE report 9069531 ↗
• MalfunctionAug 13, 2019Intermittent Continuity; Increase in Pressure; Intermittent Continuity; Increase in Pressure

  IT WAS REPORTED BY THE AFFILIATE VIA SERVICE REQUEST THAT THE FOOT PED BOARD 4WAY NEEDS SERVICE AS IT IS HAVING BAD CONTACT WHEN IT WAS WET. IT WAS MENTIONED THAT WHEN ASPIRATION PEDAL IS PRESSED THE PRESSURE GOES UP TO 120 MMHG. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8888072 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K954465. One submission often covers many models, so check the product and lot details in each record.

• Z-0658-2016 · Nov 20, 2015 · Terminated
  FMS 3.5mm Ultra-Aggressive Cutter Shaver Blades; Product Code: 287325 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.
• Z-0192-2014 · Aug 29, 2013 · Terminated
  DePuy Mitek FMS Outflow Tubing with One-Way valve Product Code:284649 Product Usage: The Intermediary Tubing for FMS Fluid Management Systems connects the Inflow Tubing to the ar