Versajet 66800044Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00040565124773), received between Oct 29, 2020 and Jun 24, 2024 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “No Flow” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT, DURING A DEBRIDEMENT, THE PUMP CARTRIDGE (METAL TIP WITH ORANGE HANDLE) OF A VERSAJET PLUS ASSY, 45 DEGREE X 14MM, SHOOT OUT OF THE CONSOLE PORT, DUE TO LACK OF TIGHTNESS OF THE SEAL. THIS OCCURRED ON A NEW REPLACED CONSOLE. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, BY CHANGING TO SURGICAL TECHNIQUES. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19596283 ↗
• MalfunctionMay 5, 2022Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT, DURING DEBRIDEMENT, BOTH VERSAJET EXACT ASSY, 45 DEGREE X 8MM AND VERSAJET PLUS ASSY, 45 DEGREE X 14MM WERE NOT DRAINING AT ALL AND INSTEAD SPRAYING BACK ALL OVER THE DEBRIDED WOUND BED. PROCEDURE WAS RESUMED, WITH A GREATER THAN 30 MINUTES DELAY, WITH A CHANGED IN SURGICAL TECHNIQUE. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN AT THE PRESENT, HOWEVER, WAS NOT HARMED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14291216 ↗
• MalfunctionOct 28, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT, BEFORE USING A VERSAJET PLUS ASSY, 45 DEGREE X 14MM HAD THE IRRIGATION HOSE CAME APART, BUT IT WAS NOT USED ON PATIENT. A NEW HANDPIECE WAS REQUIRED. TREATMENT WAS DELAYED, IT IS UNKNOW HOW MUCH TIME TOOK LONGER. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12712594 ↗
• InjuryJun 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING SURGERY PERFORMED ON (B)(6) 2021, THE VERSAJET PLUS ASSY, 45 DEGREE X 14MM MALFUNCTIONED, THE DEVICE DID NOT PERFORMED TISSUE EXCISION DESPITE OF THE LEVEL OF SPEED ADJUSTED AND ALL THE TROUBLESHOOTING WAS DONE. THE PROCEDURE PROCEED WITH MINIMAL SURGICAL DEBRIDEMENT AND LATER THEN, AUTOLYTIC DEBRIDEMENT. THE PATIENT WAS NOT HARMED. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12013101 ↗
• MalfunctionMay 13, 2021Break; Break

  IT WAS REPORTED THAT, DURING A DEBRIDEMENT PROCEDURE IN THE OP, THE METAL PART OF A VERSAJET PLUS ASSY, 45 DEGREE X 14MM BROKE OFF AT THE TOP OUTSIDE OF THE PATIENT AND NO PIECE FELL INTO THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11816105 ↗
• MalfunctionFeb 1, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE DEBRIDATION OF THE WOUND STARTED WITHOUT ISSUE BUT AFTER ONE MINUTE OF FUNCTIONING, THE DEVICE MADE A LITTLE EXPLOSION AND WATER STARTED TO COME OUT THROUGH THE HOSE THAT IS INTRODUCED TO THE DEVICE. THEN, THE DEVICE GAVE A ERROR WARNING SIGNAL AND IT DID NOT WORK AGAIN. IT DID NOT GET PRESSURE AND CONTINUOUSLY RELEASED WATER THROUGH THE HOSE. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11263010 ↗
• MalfunctionOct 30, 2020No Flow; No Flow

  IT WAS REPORTED THAT THE VERSAJET II HANDPIECE DID NOT WORK DURING A SURGERY. WATER DID NOT START TO RUN AFTER IT HAD BEEN CONNECTED. THERE WAS NO HARM DONE TO THE PATIENT AND THE OPERATION WAS ONLY DELAYED A SHORT TIME, WHILE GETTING A NEW HANDPIECE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10764339 ↗
• InjuryOct 29, 2020No Flow; No Flow

  IT WAS REPORTED THAT UNDER SURGERY, THE VERSAJET HANDSET STOPPED WORKING AFTER 10 MIN. HANDLE STOPPED PROVIDING ANY WATER AT ALL. THE PUMPING SOUND CHANGED TO A HIGHER FREQUENCY AND RATE. NO ERROR MESSAGES. SUCTION REMAINED FUNCTIONING. THERE WAS A SHORT DELAY. THE TREATMENT WAS COMPLETED BY MANUAL DEBRIDEMENT AND DUE THIS INFERIOR THERE WAS SOFT TISSUES REMOVAL, AND INCREASED RESECTION OF VITAL TISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10754331 ↗