FMS 284649Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10886705023233), received between May 9, 2018 and Apr 16, 2026 — classified as 2 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (9 reports).

3 other recalls cover devices cleared under the same FDA submission (K951843); 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 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2026Break; Leak/Splash

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPIC PROCEDURE THAT THE REUSE PATIENT SET FMS TUBING DEVICE HAD WATER BEGIN TO COME OUT THROUGH SEVERAL HOLES (IT WAS BROKEN). ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24899883 ↗
• MalfunctionAug 15, 2025Break; Mechanical Jam; Break; Mechanical Jam

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, WHILE DISCONNECTING THE TUBINGS FROM THE SHAFT OF THE REUSE PATIENT SET FMS 24PK DEVICE, THE RED PLASTIC PORTION OF THE TUBING BECAME STUCK IN THE ARTHROSCOPY SHAFT AND BROKE OFF THE REMAINING PART OF THE TUBING. THE ONLY WAY TO REMOVE THE RED PART WAS BY USING A CLAMP. THIS ISSUE WAS OBSERVED WITH TWO TUBINGS FROM THE SAME LOT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN AUGUST 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22814940 ↗
• MalfunctionAug 15, 2025Break; Mechanical Jam; Break; Mechanical Jam

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, WHILE DISCONNECTING THE TUBINGS FROM THE SHAFT OF THE REUSE PATIENT SET FMS 24PK DEVICE, THE RED PLASTIC PORTION OF THE TUBING BECAME STUCK IN THE ARTHROSCOPY SHAFT AND BROKE OFF THE REMAINING PART OF THE TUBING. THE ONLY WAY TO REMOVE THE RED PART WAS BY USING A CLAMP. THIS ISSUE WAS OBSERVED WITH TWO TUBINGS FROM THE SAME LOT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN AUGUST 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22814937 ↗
• MalfunctionJun 19, 2025Electrical /Electronic Property Problem; Increase in Pressure; Electrical /Electronic Property Problem; Increase in Pressure

  IT WAS REPORTED THAT WHEN USING THE REUSE PATIENT SET FMS, INFLOW TUBING FMS VUE, AND THE FMS VUE II PUMP-SHAVER BOX FLUID MANAGEMENT SYSTEM DEVICES, AND SYSTEM PURGING STARTS, AN FC 04 ERROR MESSAGE STARTED TO APPEAR, WHICH REFERS THAT THE PUMP HAD AN EXCESS OF PRESSURE, SO THE IRRIGATION WAS PAUSED. IT WAS REPORTED THAT THE SYSTEM WAS DISCONNECTED, AND THE TUBES WERE RE-INSTALLED, BUT THE FC 04 ERROR THAT THE PUMP SHOWED DID NOT CHANGE. IT WAS NOT REPORTED IF THE EVENT OCCURRED DURING A SURGICAL PROCEDURE. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. THE EXACT DATE OF THE EVENT WAS NOT REPORTED, HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22289667 ↗
• MalfunctionJun 9, 2025Electrical /Electronic Property Problem; Increase in Pressure; Use of Device Problem; Electrical /Electronic Property Problem; Increase in Pressure; Use of Device Problem

  REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, IT WAS OBSERVED THAT WHILE USING THE INFLOW TUBING FMS VUE 24PK DEVICE AND REUSE PATIENT SET FMS 24PK DEVICE, THE ERROR CODE FC004 WAS DISPLAYED AT THE SYSTEM PURGE, INFERRING THAT THE PUMP HAD EXCESS PRESSURE SO THE IRRIGATION WAS STOPPED. ACCORDING TO THE REPORTER, IT WAS ATTEMPTED TO RESOLVE THE ISSUE BY STARTING SEVERAL TIMES REACHING THE POINT OF TURNING OFF AND TURNING ON AND INSTALLING THE TUBES AGAIN, WHICH DID NOT WORK. IT WAS REPORTED THE PUMP MANUAL WAS REFERENCED WHERE IT INDICATED THAT THE ERROR CORRESPONDED TO A DIFFERENCE IN THE PRESSURE READERS AND THE SUGGESTION TO FIX IT WAS TO TURN OFF THE PUMP AND REPORT IT IN THE COMPANY. IT WAS REPORTED THAT THE DOCTOR COULD NOT CONTINUE WAITING FOR THE PUMP ISSUE TO BE SOLVED SINCE THERE WAS A DELAY OF SEVERAL MINUTES AT THE START OF THE SURGICAL PROCEDURE, SO HE DECIDED TO PASS THE IRRIGATION SYSTEM. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22165538 ↗
• MalfunctionMar 5, 2025Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE STERILITY OF THE REUSE PATIENT SET FMS 24PK DEVICE HAD BEEN COMPROMISED. ACCORDING TO THE REPORTER, THE ADHESIVE TAPE THAT TYPICALLY HELD THE TUBE TOGETHER WAS WELDED WITHIN THE PACKAGING, RENDERING THE DEVICE NO LONGER STERILE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21524912 ↗
• MalfunctionFeb 11, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT IT WAS OBSERVED THAT WHILE USING THE REUSE PATIENT SET DEVICE THE REF WAS PASSED NORMALLY TO THE STERILE TABLE, WHEN CONNECTING THE HOSES AND ACTIVATING THE PUMP THE SPECIALIST NOTICED A WATER LEAKAGE AT THE LEVEL OF THE CONNECTION OF THE TROCAR WITH THE TRUNK WAS VERIFIED AND THIS WAS CONFIRMED. IT WAS UNKNOWN IF THE EVENT OCCURRED DURING SURGERY. IT WAS UNKNOWN IF THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21358221 ↗
• MalfunctionNov 26, 2024Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED FROM COLOMBIA THAT WHEN THE UNSPECIFIED SURGICAL PROCEDURE WAS STARTED, AND THE PUMP INFLOW TUBING WAS PURGED AS NORMAL, AND THE ARTHROSCOPE WAS INSERTED, IT WAS OBSERVED THAT THE FMS FLUID MANAGEMENT SYSTEM MACHINE SHOWED LOW PRESSURE. THE CONSOLE WAS TURNED OFF AND THE CONVENTIONAL PUMP CONNECTION STEPS WERE REPEATED AND THE ERROR CONTINUED TO APPEAR. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20778237 ↗
• InjuryOct 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS OBSERVED THAT THE FMS FLUID MANAGEMENT SYSTEM OUTFLOW TUBING WITH ONE-WAY VALVE (FMS VUE OR FMS DUO PLUS) DEVICE HAD EXPIRED. ACCORDING TO THE REPORT, THE PROCEDURE WAS PLANNED TO HAVE A CLINICAL DEMONSTRATION OF A DUAL FLUID PUMP. IT WAS REPORTED THAT THE PATIENT WAS ANESTHETIZED, AND SIMULTANEOUSLY, AS THE PATIENT'S TUBING WAS OPENED IN THE STERILE FIELD IN ORDER TO CONNECT TO THE PUMP, THE OPERATING ROOM NURSE OBSERVED THAT ACCORDING TO THE PRODUCT PACKAGING, THE SUPPLIED PATIENT TUBING HAD EXPIRED. CONSIDERING THIS, IT WAS DECIDED NOT TO USE THE EQUIPMENT AND ALTERNATIVES WERE EXAMINED. HOWEVER, THE SURGEON DECIDED TO CANCEL THE PROCEDURE AND AWAKEN THE PATIENT. TO OUR UNDERSTANDING, THE SURGERY WILL TAKE PLACE AT A LATER DATE. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20398030 ↗
• MalfunctionOct 3, 2024Overfill; Overfill

  IT WAS REPORTED FROM COLOMBIA THAT DURING AN ARTHROSCOPIC SURGICAL PROCEDURE THE REUSE PATIENT SET FMS DEVICE WHEN USING THE INPUT OF THE PUMP, IT WAS EVIDENCED THAT THE WATER RESERVOIR WAS COMPLETELY FILLED, SO THE PROCEDURE WAS INTERRUPTED UNTIL IT WAS RESOLVED SINCE THE FILTER HAD BEEN WET, A NEW INPUT OF ANOTHER BRAND WAS USED. THE PROCEDURE WAS APPROXIMATELY 20 MINUTES OVERTIME. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20358094 ↗
• MalfunctionSep 6, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED BY THE SALES REP THAT A HUMAN HAIR WAS FOUND INSIDE THE REUSE PATIENT SET FMS 24PK STERILE PACKAGING PRIOR TO BEING OPENED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20162560 ↗
• MalfunctionJun 4, 2024Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT DURING AN UNSPECIFIED HIP SURGERY, IT WAS OBSERVED THAT THE REUSE PATIENT SET FMS DEVICE STOPPED PUMPING. IT WAS BELIEVED THAT A ONE-WAY VALVE WAS FAULTY. IT WAS REPORTED THAT THERE WAS A TEN MINUTE DELAY IN THE SURGICAL PROCEDURE. IT WAS REPORTED THAT 2 FMS WERE TURNED ON AND MOVED TO MANUAL TO HAND PUMP. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 19458473 ↗
• MalfunctionMay 24, 2024Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED BY THE BY THE HEALTHCARE PROFESSIONAL IN SWITZERLAND THAT DURING AN ARTHROSCOPY PROCEDURE ON (B)(6) 2024, WHEN USING THE REUSE PATIENT SET FMS 24PK DEVICE AND CONNECTING THE FMS VUE INFLOW TUBING TO THE SHAFT OF THE ARTHROSCOPE, THE INNER PLASTIC BROKE OFF, LEADING TO A LEAKAGE ON THE ARTHROSCOPE. ACOORDING TO THE REPORTER, IT CANNOT BE RULED OUT THAT THE BREAKAGE WAS CAUSED BY ROUGH CONNECTION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A THREE MINUTE DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19389835 ↗
• MalfunctionMay 9, 2024Leak/Splash; Use of Device Problem; Leak/Splash; Use of Device Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE REUSE PATIENT SET FMS DEVICE AND THE INFLOW TUBING FMS VUE DEVICES WERE BEING USED WHEN THE TWO HOSES DID NOT ALLOW THE PUMP TO WORK AND THE WATER WAS DUMPED OR WATERED, WHICH IS WHY WE HAD TO OPEN THE OTHER TWO SPARE HOSES SO THAT THE PUMP COULD START AND FUNCTION CORRECTLY, WHICH DELAYED THE SURGERY FOR APPROXIMATELY 1 HOUR, THE TIME IN WHICH THE PUMP AND HOSES WERE TESTED UNTIL THEY WORKED CORRECTLY. THE SURGERY WAS FINALLY COMPLETED SUCCESSFULLY BUT WITH EFFECTS ON THE PATIENT SINCE IT WAS NECESSARY TO EXTEND HIS ANESTHESIA TIMES. YES, THE PATIENT WAS AFFECTED SINCE IT WAS NECESSARY TO INTRAOPERATIVELY EXTEND HIS ANESTHESIA TIMES DUE TO THE DELAY OF APPROXIMATELY 1 HOUR IN SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19276406 ↗
• MalfunctionMay 7, 2024Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE INNER PLASTIC ON THE MS FLUID MANAGEMENT SYSTEM OUTFLOW TUBING WITH ONE-WAY VALVE DEVICE BROKE OFF CAUSING A LEAKAGE. THE PROCEDURE WAS COMPLETED WITH A DELAY OF FIVE MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITION INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19260172 ↗
• MalfunctionApr 25, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED FROM THE PHILIPPINES THAT DURING AN ARTHROSCOPY SURGICAL PROCEDURE THE REUSE PATIENT SET FMS DEVICE IN/OUT FLOW TUBING WAS DEFECTIVE AND LEAKING. MANUAL TUBING WAS USED INSTEAD TO CONTINUE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19180530 ↗
• MalfunctionMar 25, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE REUSE PATIENT SET FMS 24PK DEVICE WAS BEING USED WHEN A PATIENT MANAGED FOR NEUROGENIC CLAUDICATION OF THE LOWER LIMBS ON A NARROW LUMBAR CANAL L4-L5 WITH SPONDYLOLISTHESIS. DURING THE ARTHROSCOPIC SURGICAL PROCEDURE, THE HEALTH-CARE PROFESSIONAL NOTICED A LACK OF ASPIRATION. NO ERROR MESSAGE APPEARED ON THE VAPR VUE GENERATOR. NO DEFECT WAS VISIBLE ON THE TUBING. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18968065 ↗
• MalfunctionFeb 12, 2024Increase in Pressure; Overfill; Appropriate Device Problem Term/Code Not Available; Increase in Pressure; Overfill; Appropriate Device Problem Term/Code Not Available

  THIS IS REPORT 2 OF 2 FOR : (B)(4). IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN COLOMBIA THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2024, ONCE THE SURGICAL PROCEDURE WAS STARTED, IT WAS OBSERVED THAT THE INFLOW TUBING FMS VUE 24PK DEVICE AND REUSE PATIENT SET FMS 24PK DEVICE WERE CONNECTED IMMEDIATELY, AN ANOMALY WAS NOTED SINCE THE FILTER WAS FILLED TO ITS TOP WHEN RUNNING, WHICH CAUSED PRESSURE ON THE JOINT. THE CONSOLE SITE WAS MODIFIED (THE DOCTOR ASSUMED IT WAS VERY LOW, ELEVATED ON A HIGHER TABLE) IT TURNED OFF AND ON, BUT IT DID NOT WORK, SO THE DOCTOR REQUESTED NOT TO CHARGE THE SET OF PIPES, PASSES AND TOUR TO REPLACE THE FMS. THE PROCEDURE WAS COMPLETED WITHOUT ANY NEW DEVELOPMENTS. 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 18689777 ↗
• MalfunctionOct 18, 2023Improper Flow or Infusion; Improper Flow or Infusion

  THIS IS REPORT 1 OF 3 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN COLOMBIA THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE UNK - FLUID MANAGEMENT SYSTEM PUMP DEVICE WAS NOT GIVING ADEQUATE PRESSURE WHEN USED WITH A REUSE PATIENT SET FMS 24PK AND INFLOW TUBING FMS VUE 24PK. IT WAS REPORTED THAT THE PRESSURE IN THE PUMP INCREASED, THE CONNECTIONS WERE CHECKED, YET THE PHYSICIAN INDICATED THAT THERE WAS NO PRESSURE. 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 17959565 ↗
• MalfunctionNov 1, 2022Backflow; Defective Device; Backflow; Defective Device

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN SWITZERLAND THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022 , IT WAS OBSERVED THAT THE WATER FROM THE OUTFLOW RAN BACK TO THE SHAVER WHILE USING THE FMS FLUID MANAGEMENT SYSTEM OUTFLOW TUBING W/ONE-WAY VALVE (FMS VUE OR FMS DUO) DEVICE. 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 15710384 ↗
• MalfunctionSep 13, 2022Device Remains Activated; Overfill; Improper Flow or Infusion; Device Remains Activated; Overfill; Improper Flow or Infusion

  THIS IS REPORT 2 OF 4 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN SWITZERLAND THAT PREOPERATIVELY TO AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT AN UNKNOWN PUMP DEVICE HAD NO PRESSURE WHEN THREE TUBING DEVICES WERE CONNECTED INDIVIDUALLY THAT THE CHAMBER OVERFILLED WITHOUT STOPPING. 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 15411502 ↗
• MalfunctionMay 7, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE TUBING DEVICE WHILE IN USE WITH THE FMS VUE FLUID MANAGEMENT SYSTEM PUMP DEVICE WAS NOT SUCTIONING. THE REP TRIED TO CHANGE THE PUMP AND TUBING ON THE WITHOUT RESOLUTION. THE SAME 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 11792591 ↗
• MalfunctionFeb 19, 2021Crack; Leak/Splash; Crack; Leak/Splash

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN ARTHROSCOPIC SHOULDER STABILIZATION PROCEDURE ON 2/5/2021, IT WAS OBSERVED THAT THE IRRIGATION PUMP DEVICE HAD A WATER LEAK IN THE HOSE THAT IT WAS SPLIT IN THE CENTER. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11349316 ↗
• MalfunctionSep 30, 2020Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED BY AFFILIATE VIA COMPLAINT SUBMISSION TOOL THE REUSE PATIENT SET FMS 24PK. UPON SETTING UP THE FMS, THE WATER DOESN'T FLOW UP TO THE SCOPE. NOTICED INCREASED PRESSURE ON THE BAG AND WATER DOESN'T FLOW. THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED SURGICAL DELAY OR PATIENT IMPACT DID NOT OCCUR DUE TO THE REPORTED EVENT. IT WAS ALSO REPORTED THE CASE WAS SUCCESSFULLY COMPLETED BY USING THE SAME DEVICE BUT BY PRICKING THE POUCH OF THE PRODUCT WITH A NEEDLE IN ORDER TO INCREASE WATER FLOW.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10605174 ↗
• MalfunctionOct 17, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN UNKNOWN PROCEDURE THAT THE RED TAPE ON THE CUSTOMER'S FMS FLUID MANAGEMENT SYSTEM OUTFLOW TUBING WITH ONE WAY VALVE WAS STUCK TO THE INTERIOR LID AND WHEN THEY WENT TO PULL OFF THE INTERIOR LID, THE TUBING CAME WITH IT. THE CONTAINER SPILLED ALL OVER THE TUBING AND CONTAMINATED IT. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE DEVICE WITH NO PATIENT HARM OR SURGICAL DELAY TO THE CASE. THE SALES REP WAS NOT PRESENT FOR THE CASE THEREFORE COULD NOT PROVIDE ANY FURTHER INFORMATION. THE DEVICE WILL BE RETURNING FOR EVALUATION. THIS COMPLAINT IS FOR ONE (1) FMS FLUID MANAGEMENT SYSTEM OUTFLOW TUBING W/ONE-WAY VALVE (FMS VUE OR FMS DUO). THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9205537 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K951843. One submission often covers many models, so check the product and lot details in each record.

• Z-0191-2014 · Aug 29, 2013 · Terminated
  DePuy Mitek FMS Intermediary Tubing with One-Way valve Product Code: 281142 Product Usage: The Intermediary Tubing for FMS Fluid Management Systems connects the Inflow Tubing to
• Z-1948-2011 · Dec 3, 2010 · Terminated
  DePuy Mitek FMS Irrigation Intermediary Tube Without One-way Valve Arthroscopy tubing (100 units/box) (International Distribution Only) Product Code: 281102 Fluid Tissue Management
• Z-1946-2011 · Dec 3, 2010 · Terminated
  DePuy Mitek FMS Irrigation Intermediary Tube With One-way Valve Arthroscopy tubing Product Code: 281142 Fluid Tissue Management