VAPR 227305Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10886705009718), received between Dec 17, 2018 and Aug 27, 2026 — classified as 3 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Break” (8 reports).

2 other recalls cover devices cleared under the same FDA submission (K082643); 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. 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2026Product Quality Problem; Device Damaged Prior to Receipt by User; Use of Device Problem

  It was reported that during an in-house engineering evaluation, the VAPR 3.5MM HOOK 1-PIECE ELECTRODE device was found damaged upon receipt. It was initially reported that during an unspecified surgical procedure, the doctor dropped the tripolar device and used the VAPR 3.5MM HOOK 1-PIECE ELECTRODE. Upon opening the electrode, the hook tip was observed missing. The electrode was sent marked with red tape. There were no delays to the surgical procedure. 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 50474054 ↗
• MalfunctionJun 3, 2026Break; Use of Device Problem

  IT WAS REPORTED THAT DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE VAPR 3.5MM HOOK 1-PIECE ELECTRODE DEVICE WAS BROKEN (2+ PIECES) : DEVICE FRACTURED. IT WAS INITIALLY REPORTED THAT DURING AN ARTHROSCOPIC RECONSTRUCTION OF ANKLE LIGAMENT SURGERY, THE DEVICE FAILED TO FUNCTION. THERE WERE NO DELAYS IN THE SURGICAL PROCEDURE. IT WAS REPORTED THAT A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY. 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 25377189 ↗
• MalfunctionFeb 13, 2026Device Damaged Prior to Receipt by User

  DURING A KNEE SURGERY, AN ISSUE AROSE WITH A NEW, UNOPENED RADIOFREQUENCY HOOK DEVICE. WHEN THE PEDAL OF THE VAPR 3.5MM HOOK 1-PIECE ELECTRODE -EA WAS PRESSED INSIDE THE JOINT USING AN AQUEOUS MEDIUM, IT FAILED TO ACTIVATE. THE CONSOLE WAS RESTARTED AND RECONNECTED, BUT THE ERROR PERSISTED. THE SURGEON ATTEMPTED TO USE THE HOOK DEVICE MORE THAN THREE TIMES, BUT IT DID NOT WORK. THEREFORE, ANOTHER DEVICE WAS USED AND THE SURGEON CONTINUED THE SURGICAL PROCEDURE WITHOUT FURTHER INCIDENT. THE FAULTY DEVICE WAS REMOVED AND THE PROCEDURE WAS EXTENDED BY APPROXIMATELY 10 MINUTES DUE TO THIS ISSUE. A TRIPOLAR RADIOFREQUENCY TIP WAS USED TO REPLACE THE REPORTED MEDICAL DEVICE. THIS CHANGE OCCURRED WITHOUT CAUSING HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24334618 ↗
• MalfunctionFeb 5, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC RELEASE OF CONTRACTURE OF THE PATIENT'S RIGHT FROZEN SHOULDER SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE HOOK COMPONENT OF THE ELECTRODE 'FELL OFF.' ACCORDING THE REPORT, THE HOOK DID NOT COME OFF WHEN IT WAS BEING ACTIVELY USED, BUT INSTEAD JUST AS THE USER COMPLETED THE PROCEDURE AND WAS BEGINNING TO WITHDRAW THE ELECTRODE FROM THE SHOULDER. THE HOOK FELL OFF AND WAS SEEN TO BE LYING ON THE UPPER SURFACE OF THE LONG HEAD OF BICEPS. HOWEVER, IT THEN FELL INTO THE DEPTHS OF THE SHOULDER BEFORE THE USER COULD RETRIEVE IT. AS THIS OCCURRED AT THE CONCLUSION OF THE ARTHROSCOPIC RELEASE, THE HOOK FELL INTO THE AXILLARY RECESS OF THE SHOULDER THAT HAD ALREADY BEEN RELEASED SUCH THAT THE RETAINED HOOK WOULD HAVE BECOME EXTRACAPSULAR (I.E. OUTSIDE OF THE SHOULDER COMPARTMENT). IT WAS THEREFORE UNRETRIEVABLE AS WAS DEMONSTRATED BY AN XRAY TAKEN FOLLOWING THE PROCEDURE. CONSEQUENCES OF MALFUNCTION: THE PATIENT WILL REQUIRE REGULAR MRI SCANS FOR CONFIRMATION THAT ITS RETENTION DOES NOT EXCLUDE THE USE OF AN MRI SCAN IN THE FUTURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 24268815 ↗
• MalfunctionJan 12, 2026Device Damaged Prior to Receipt by User

  IT WAS REPORTED THAT PRIOR TO AN UNSPECIFIED SURGICAL PROCEDURE, WHEN THE PACKAGING OF THE VAPR 3.5MM HOOK 1-PIECE ELECTRODE DEVICE WAS OPENED, IT WAS OBSERVED THAT THERE WAS A SMALL CRACK IN THE COATING. THE PRODUCT WAS NOT USED IN THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24032664 ↗
• MalfunctionDec 13, 2025Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  IT WAS REPORTED THAT PRIOR TO AN UNSPECIFIED SURGICAL PROCEDURE, TWO VAPR 3.5MM HOOK 1-PIECE ELECTRODE DEVICES WERE BOTH ALREADY DAMAGED WHEN THE PACKAGING WAS OPENED, A THIRD VAPR 3.5MM HOOK 1-PIECE ELECTRODE DEVICE WAS MISSING A TIP, AND THE FOURTH VAPR 3.5MM HOOK 1-PIECE ELECTRODE DEVICE WAS BENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. 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 23797827 ↗
• MalfunctionDec 13, 2025Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  IT WAS REPORTED THAT PRIOR TO AN UNSPECIFIED SURGICAL PROCEDURE, TWO VAPR 3.5MM HOOK 1-PIECE ELECTRODE DEVICES WERE BOTH ALREADY DAMAGED WHEN THE PACKAGING WAS OPENED, A THIRD VAPR 3.5MM HOOK 1-PIECE ELECTRODE DEVICE WAS MISSING A TIP, AND THE FOURTH VAPR 3.5MM HOOK 1-PIECE ELECTRODE DEVICE WAS BENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23797817 ↗
• MalfunctionDec 13, 2025Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  IT WAS REPORTED THAT PRIOR TO AN UNSPECIFIED SURGICAL PROCEDURE, TWO VAPR 3.5MM HOOK 1-PIECE ELECTRODE DEVICES WERE BOTH ALREADY DAMAGED WHEN THE PACKAGING WAS OPENED, A THIRD VAPR 3.5MM HOOK 1-PIECE ELECTRODE DEVICE WAS MISSING A TIP, AND THE FOURTH VAPR 3.5MM HOOK 1-PIECE ELECTRODE DEVICE WAS BENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23797814 ↗
• MalfunctionNov 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGERY, IT WAS OBSERVED THAT THE VAPR 3.5MM HOOK 1-PIECE ELECTRODE DEVICE WHITE PART OF THE HOOK BROKE DOWN. 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 23580984 ↗
• MalfunctionOct 27, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING A MEDIAL PATELLOFEMORAL LIGAMENT (MPFL) RECONSTRUCTION ON THE KNEE, THE VAPR 3.5MM HOOK DEVICE SUDDENLY WENT INTO EVAPORATION MODE WITHOUT ANY OPERATION BEING PERFORMED ONCE IT WAS CONNECTED TO THE MAIN UNIT. IT WAS REPORTED THAT THE CORD WAS HASTILY UNPLUGGED FROM THE MAIN UNIT. WHEN THE MAIN UNIT WAS RESTARTED AND THE PRODUCT IN QUESTION WAS PLUGGED IN AGAIN, THE SAME PROBLEM OCCURRED. USE OF THE ELECTRODE DEVICE WAS DISCONTINUED. THEREFORE, A NEW UNKNOWN ELECTRODE WAS OPENED AND INSERTED, BUT THE SAME PROBLEM OCCURRED. ACCORDING TO THE REPORTER, A PROBLEM WITH THE MAIN UNIT OR FOOT SWITCH WAS SUSPECTED. THE UNKNOWN FOOT SWITCH DEVICE WAS REPLACED, THE UNKNOWN ELECTRODE WAS TRIED AGAIN, AND IT WORKED WITHOUT ANY PROBLEMS. ACCORDING TO THE REPORTER, IT WAS DETERMINED THAT THE FOOT SWITCH WAS FAULTY. THERE WAS 30 MINUTES SURGICAL DELAY AND NO HARM TO THE PATIENT. THE ELECTRODE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23397672 ↗
• MalfunctionSep 15, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR SURGERY, IT WAS OBSERVED THAT THE VAPR 3.5MM HOOK 1-PIECE ELECTRODE DEVICE COULD NOT CUT AND COULD NOT COAGULATE. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23052538 ↗
• MalfunctionJul 31, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPY SURGICAL PROCEDURE, WHEN USING THE VAPR 3.5MM HOOK 1-PIECE ELECTRODE DEVICE, IT WAS OBSERVED THAT PART OF THE COATING CAME OFF AND THE HOOK BROKE. IT WAS REPORTED THAT THE DEVICE WAS NEW. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22675198 ↗
• MalfunctionJul 16, 2025Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE AIMED AT TREATING THE ¿MPFL,¿ THE TIP OF THE VAPR 3.5MM HOOK 1-PIECE ELECTRODE DEVICE WAS FOUND TO BE DAMAGED. IT WAS REPORTED THAT THE NURSE NOTICED AN ABNORMALITY WITH THE DEVICE WHEN THEY OPENED IT AND WERE PREPARING TO HAND IT OVER TO A SCRUB NURSE. THERE WAS THIRTY-MINUTE DELAY TO THE SURGICAL PROCEDURE. A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY. 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 22522424 ↗
• MalfunctionJan 21, 2025

  UPON OPENING DEVICE, THE PHYSICIAN NOTICED THERE SHOULD BE A HOOK ON THE END OF THE DEVICE BUT NO HOOK WAS PRESENT. PHYSICIAN OPENED A NEW DEVICE AND THAT WAS USED FOR THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21196572 ↗
• MalfunctionSep 30, 2024Use of Device Problem; Blocked Connection; Use of Device Problem; Blocked Connection

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN COLOMBIA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2024, IT WAS OBSERVED THAT IN THE MIDDLE OF THE PROCEDURE A VAPR HOOK ELECTRODE DEVICE WAS REQUIRED TO RELEASE THE RETINACULUM. ACCORDING TO THE REPORTER WHEN THE IMPLANT WAS PASSED TO THE TABLE, THE PEDAL WAS ACTIVATED, BUT IT DID NOT WORK BECAUSE THE CONSOLE DID NOT RECOGNIZE THE DEVICE. IT WAS REPORTED THAT THE DOCTOR REITERATED THAT HE DID NOT ALLOW THE IMPLANT TO BE CHARGED. THERE WAS NO PATIENT CONSEQUENCE. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 20331851 ↗
• MalfunctionMar 25, 2024Melted; Melted

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE IT WAS OBSERVED THAT THE TIP OF THE VAPR HOOK ELECTRODE 3.5MM DEVICE STARTED TO MELT. IT WAS REPORTED THAT THE PROCEDURE WAS FINISHED BY THE TIME IT WAS NOTICED THAT THE TIP HAD MELTED. THERE WAS NO ADVERSE PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18968930 ↗
• MalfunctionFeb 2, 2024Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED BY THE SALES REP IN JAPAN THAT PREOPERATIVELY TO AN UNKNOWN PROCEDURE ON (B)(6) 2024, IT WAS OBSERVED THAT THE TIP ON THE VAPR 3.5MM HOOK 1-PIECE ELECTRODE DEVICE WAS BROKEN WHEN THE PACKAGE OF THE PRODUCT WAS OPENED. 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 18632842 ↗
• MalfunctionJan 11, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP IN JAPAN THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) PROCEDURE FOR A ROTATOR CUFF TEAR PERFORMED ON (B)(6) 2023, THE VAPR 3.5MM HOOK 1-PIECE ELECTRODE -EA DEVICE WAS USED WITH A SHOULDER ARTHROSCOPE, AND THE HOOK METAL AT THE ELECTRODE TIP BROKE AND FELL INTO THE BODY. THE BROKEN METAL PIECE WAS REMOVED FROM THE BODY, AND THERE WERE NO BROKEN PIECES IN THE BODY. A NEW SAME DEVICE WAS USED FOR THE SURGERY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. IT WAS REPORTED THAT THE SURGEON COMMENTED THAT THE ELECTRODE IN QUESTION WAS USED TO CUT SOFT TISSUE, SO THAT IF IT WERE DAMAGED AT THIS LEVEL, IT WOULD BE TOO DANGEROUS TO USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18492563 ↗
• MalfunctionDec 20, 2023Blocked Connection; Blocked Connection

  IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE VAPR 3.5MM HOOK 1-PIECE ELECTRODE -EA DEVICE WAS NOT READ BY THE CONSOLE AND ONLY THE 90° TRIPOLAR WORKED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A FIVE 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 18362881 ↗
• MalfunctionMar 10, 2023Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE BLACK VINYL OVER THE TIP ON THE VAPR HOOK ELECTRODE 3.5MM HOOK ELECTRODE W/INTEGRATED HANDPIECE DEVICE WAS SEVERELY (OR WIDELY) BROKEN AFTER SURGERY. ACCORDING TO THE REPORT, THE SURGEON DID NOT NOTICE THE BREAKAGE DURING USE. 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 16524234 ↗
• MalfunctionNov 15, 2022Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE WHITE PART OF THE HOOK OF THE VAPR HOOK ELECTRODE 3.5MM HOOK ELECTRODE W/INTEGRATED HANDPIECE DEVICE BROKE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15799340 ↗
• InjuryJan 14, 2022Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ARTHROSCOPIC CAPSULAR RELEASE OF FROZEN SHOULDER FOR TREATING SHOULDER CONTRACTURE SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE TIP ON THE VAPR 3.5MM HOOK 1-PIECE ELECTRODE DEVICE BROKE OFF WHILE IN USE. ACCORDING TO THE REPORT, THE BROKEN FRAGMENT WAS NOT LOCATED IN THE JOINT. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER SEARCHING FOR THE FRAGMENT WITH LESS THAN 30 MINUTES OF DELAY. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13258656 ↗
• InjurySep 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE PATIENT SUFFERED FROM A LIGHT BURN WHILE IN USE OF THE EVAPR 3.5MM HOOK 1-PIECE ELECTRODE DEVICE. THERE WAS NO SURGICAL DELAY. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. THE STATUS OF THE PATIENT POST-SURGERY WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Burn(s)

  MAUDE report 12536521 ↗
• InjurySep 21, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE VAPR 3.5MM HOOK 1-PIECE ELECTRODE DID NOT HAVE THE HOOK PART AFTER IT WAS USED ON THE PATIENT. THE SURGEON DECIDED TO EXPLORE THE SHOULDER JOINT SINCE THAT WAS WHERE IT DETACHED BUT UNABLE TO FIND IT. IT WAS REPORTED THAT THE SURGEON DECIDED TO CONTINUE WITH THE PROCEDURE WITHOUT FINDING THE TIP. THE STATUS OF THE PATIENT POST-SURGERY WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12509389 ↗
• MalfunctionMay 7, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP VIA CST THAT DURING A KNEE ARTHROSCOPY, IT WAS OBSERVED THAT THE TIP OF THE 3.5 VAPR HOOK ELECTRODE CAME OFF AS THE SURGEON PULLED THE PROBE OUT OF THE KNEE JOINT. THERE WAS A TWO MINUTE DELAY AS THE BROKEN PIECE WAS REMOVED WITH AN ARTHROSCOPIC GRASPER. THE CASE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER SURGICAL INTERVENTION AS SEVERAL PROBES WERE READILY AVAILABLE. THERE WAS NO PATIENT CONSEQUENCE. 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: Not Applicable

  MAUDE report 8586949 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082643. One submission often covers many models, so check the product and lot details in each record.

• Z-0133-2013 · Mar 12, 2012 · Terminated
  DePuy Mitek VAPR Hook Electrode 3.5mm Hook Electrode with Integrated Handpiece Catalog Number: 227305 The DePuy Mitek VAPR Electrodes for use with the VAPR Radiofrequency Syste
• Z-2301-2010 · Jun 7, 2010 · Terminated
  Mitek VAPR Side Effect Electrode (integrated) Product Code: 227301 The VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) and V