VAPR 228504Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 10886705020942), received between Sep 3, 2018 and Jun 25, 2026 — classified as 50 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (22 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. 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 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2026Output Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGERY, THE VAPR DEVICE WORKED INTERMITTENTLY. CHANGED TO ANOTHER VAPR DEVICE TO CONTINUE THE SURGERY BUT THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25622396 ↗
• MalfunctionJun 3, 2026Infusion or Flow Problem; Device Contaminated During Manufacture or Shipping; Output Problem

  IT WAS REPORTED THAT DURING A MENISCAL REPAIR SURGICAL PROCEDURE, WHILE USING THE VAPR P50 W/ HAND CONTROLS DEVICE, IT WAS OBSERVED THAT AN ABNORMALITY ALARM WAS FOUND. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT TISSUE DEBRIS WAS IN THE ACTIVE TIP, SALINE CRYSTALLIZATION ON THE TIP AND ESCHAR BUILD UP ON MANIFOLD. IT WAS FURTHER DETERMINED THAT THERE WAS SUCTION FAILURE. 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 25379840 ↗
• MalfunctionJun 2, 2026Electrical /Electronic Property Problem; Melted; Device Contaminated During Manufacture or Shipping; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY HIP GLUTEAL MUSCLE CONTRACTURE SURGICAL PROCEDURE, WHEN USING THE VAPR P50 W/ HAND CONTROLS DEVICE, IT WAS OBSERVED THAT THE BUTTONS FAILED, AND THE DEVICE DID NOT OPERATE WHEN THE BUTTONS WERE DEPRESSED. IT WAS REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THE COAGULATION TEST DID NOT WORK AS INTENDED, AND THE TIP COMPONENTS WERE IN USED CONDITION, WITH SOME RESIDUE AROUND THE MANIFOLD AND THE ACTIVE TIP WAS CHARRED. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25363867 ↗
• MalfunctionJun 30, 2025Device Remains Activated; Physical Resistance/Sticking; Device Remains Activated; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, IT WAS OBSERVED THAT MULTIPLE BUTTON OF THE VAPR P50 W/ HAND CONTROLS DEVICE WERE PRESSED AND THE RF WAND WAS STILL WORKING AND COULD NOT CLOSE. 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 22356844 ↗
• MalfunctionJan 2, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  REPORT 1 OF 3 FOR (B)(4). IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE VAPR P50 W/ HAND CONTROLS DEVICE GENERATED SPARKS. ACCORDING TO THE REPORTER, CHANGED TO ANOTHER TWO DEVICES TO CONTINUE THE SURGERY AND THE SAME PROBLEM HAPPENED AGAIN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE 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 21053903 ↗
• MalfunctionOct 22, 2024Break; Electrical /Electronic Property Problem; Use of Device Problem; Break; Electrical /Electronic Property Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING A MENISCAL REPAIR PROCEDURE, IT WAS OBSERVED THAT THE VAPR P50 W/ HAND CONTROLS DEVICE DID NOT WORK; AND AN OUTPUT SHORT ERROR APPEARED. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE SUCTION TUBE ON THE DEVICE WAS CUT OFF. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20506776 ↗
• MalfunctionAug 15, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED FROM CHINA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE, IT WAS OBSERVED THAT THE VAPR PREMIERE50 ELECTRODE WITH HAND CONTROLS 3.0MM, 50 DEGREES SUCTION WITH INTEGRATED HANDPIECE DEVICE COULD NOT CUT (ABLATE). DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE COULD NOT COAGULATE AS IT FAILED THAT HIPOT ACTIVATE-RETURN ELECTRICAL TESTING AND THE ACTIVATION FUNCTIONAL TEST. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19991892 ↗
• MalfunctionJun 5, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THIS IS REPORT 2 OF 4 FOR (B)(4). IT WAS REPORTED FROM CHINA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS OBSERVED THAT THE VAPR P50 W/ HAND CONTROLS DEVICE GENERATED SPARKS; AND THEREFORE, WAS NOT USED ON THE PATIENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19467776 ↗
• MalfunctionJan 12, 2024Device Reprocessing Problem; Output Problem; Device Reprocessing Problem; Output Problem

  IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE VAPR P50 W/ HAND CONTROLS DEVICE AFTER CONNECT WITH GENERATOR, AN ALARM SOUND APPEARS. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD INTERMITTENT OPERATION AND FOREIGN SUBSTANCE/DEBRIS/CLEANING. 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 18505885 ↗
• MalfunctionOct 19, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6)2023 THE VAPR P50 W/ HAND CONTROLS DEVICE HAD NO SUCTION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE 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 17966599 ↗
• MalfunctionJul 6, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING A KNEE ARTHROSCOPY PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE VAPR PREMIERE50 ELECTRODE W/HAND CONTROLS, 3.0MM, 50° SUCTION W/INTEGRATED HANDPIECE DEVICE HAD AN ELECTRICAL SHORT. 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 17270940 ↗
• MalfunctionApr 19, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE VAPR PREMIERE50 ELECTRODE W/HAND CONTROLS, 3.0MM, 50° SUCTION W/INTEGRATED HANDPIECE DEVICE HAD NO SUCTION. 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 16771379 ↗
• MalfunctionFeb 22, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED BY THE SALES REP IN CHILE THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE VAPR PREMIERE50 ELECTRODE W/HAND CONTROLS, 3.0MM, 50° SUCTION W/INTEGRATED HANDPIECE DEVICE WAS DEFICIENT IN COAGULATION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF 15 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16420734 ↗
• MalfunctionFeb 3, 2021Electrical /Electronic Property Problem; Power Problem; Electrical /Electronic Property Problem; Power Problem

  IT WAS REPORTED BY THE AFFILIATE IN CHILE THAT DURING A KNEE ARTHROSCOPY PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE COAGULATION FUNCTIONALITY ON THE VAPR P50 W/ HAND CONTROLS DEVICE DID NOT WORK EVEN AT MAXIMUM POWER. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A 10 MINUTE DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11273445 ↗
• MalfunctionOct 22, 2020Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED BY THE SALES REP THAT ONE VAPR PREMIERE50 ELECTRODE W/HAND CONTROLS WAS DAMAGED UPON RECEIPT. THE DEVICES WERE NOT USED. NO PROCEDURE, OR PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10717517 ↗
• MalfunctionOct 16, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT DURING THE ACL OPERATION, AFTER CONNECT WITH GENERATOR, DOES NOT FUNCTION AT ALL, THE SCREEN DID NOW SHOW ANY ALERT CODE. 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 Consequences Or Impact To Patient

  MAUDE report 10693421 ↗
• MalfunctionApr 22, 2020Blocked Connection; Blocked Connection

  IT WAS REPORTED BY AFFILIATE VIA EMAIL THAT DURING AN ARTHRO PROCEDURE PERFORMED, THE VAPR P50 W/ HAND CONTROLS WASN'T RECOGNIZED. NO PATIENT CONSEQUENCE. THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9988444 ↗
• MalfunctionDec 12, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED BY AFFILIATE VIA EMAIL THAT DURING A KNEE ARTHROSCOPY THE COAGULATION BUTTON OF THE VAPR P50 W/ HAND CONTROLS DIDN¿T WORKED, IT WAS ALSO TESTED WITH THE PEDAL AND IT DIDN¿T COAGULATE, THE CONSOLE WAS SWITCHED AND THE FAILURE CONTINUED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9460753 ↗
• MalfunctionDec 4, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT DURING A MENISCECTOMY THE VAPR P50 W/ HAND CONTROLS DIDN¿T RESPOND WHEN COAGULATING, AND THE RADIO FREQUENCY CUT FUNCTION. SURGEON OPENED A NEW VAPR PREMIERE50 ELECTRODE -EA WITH NEW CODE BUT SAME SIZE AND AGAIN IT DIDN¿T COAGULATE. THE PROCEDURE WAS COMPLETED USING A DEVICE FROM A DIFFERENT COMPANY. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9413439 ↗
• MalfunctionDec 4, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED BY THE AFFILIATE IN CHILE THAT DURING A KNEE ARTHROSCOPY, IT WAS OBSERVED THAT THE VAPR P50 W/ HAND CONTROLS DEVICE FAILED TO COAGULATE. AS PER THE AFFILIATE, THE SURGEON TRIED RESOLVING THE ISSUE BY CONNECTING THE PEDAL BUT THE ISSUE PERSISTED. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER DEVICE THAT PRESENTED VERY WEEK COAGULATION. ONCE THE PROCEDURE WAS COMPLETED BOTH OF THE RADIO FREQUENCIES WERE TESTED USING ANOTHER CONSOLE BUT THE FAILURE CONTINUED. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE. THERE WAS A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS 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 Consequences Or Impact To Patient

  MAUDE report 9413046 ↗
• MalfunctionNov 25, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A KNEE ARTHROSCOPY, IT WAS OBSERVED THAT THE VAPR P50 W/ HAND CONTROLS DEVICE FAILED TO COAGULATE. AS PER THE AFFILIATE, THE SURGEON TRIED RESOLVING THE ISSUE BY CONNECTING THE PEDAL BUT THE ISSUE PERSISTED. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER DEVICE THAT PRESENTED VERY WEEK COAGULATION. ONCE THE PROCEDURE WAS COMPLETED BOTH OF THE RADIO FREQUENCIES WERE TESTED USING ANOTHER CONSOLE BUT THE FAILURE CONTINUED. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE. THERE WAS A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS 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 Consequences Or Impact To Patient

  MAUDE report 9370920 ↗
• MalfunctionNov 19, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT DURING AN UNKNOWN PROCEDURE THE VAPR P50 W/ HAND CONTROLS DIDN¿T WORKED. ANOTHER UNIT HAD TO BE USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED THE EXACT FAILURE OF THE ELECTRODE WAS THAT THE HAND PIECE DID NOT FUNCTION AT ALL; WHEN A BUTTON WAS DEPRESSED NOTHING OCCURRED. IT WAS ALSO REPORTED THAT A SMALL SURGICAL DELAY OCCURRED AND THERE WERE NO KNOWN CONSEQUENCES TO THE PATIENT OR USER. THE AFFILIATE REPORTED THE KNEE ARTHROSCOPY PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE HAND PIECE AND ADDITIONAL SURGICAL INTERVENTION WAS NOT REQUIRED. IN HOUSE EVALUATION OF THE RETURNED DEVICE FOUND THAT THE ELECTRODE EXHIBITED NO OUTPUT WHEN THE COAGULATION OR ABLATION FUNCTION WERE ACTIVATED. THE ELECTRODE WAS SENT TO THE SUPPLIER FOR AN IN-DEPTH INVESTIGATION.

  Patient problems: Not Applicable

  MAUDE report 9344122 ↗
• MalfunctionOct 31, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE AFFILIATE VIA EMAIL DURING AN UNKNOWN PROCEDURE ON OCTOBER 8, 2019, THE VAPR P50 W/ HAND CONTROLS DIDN¿T COAGULATE AND DIDN¿T ABLATE. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT. THERE WAS SURGICAL DELAY OF APPROXIMATELY FIFTEEN (15) MINUTES. NO PATIENT CONSEQUENCE WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9263192 ↗
• MalfunctionOct 28, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019 DURING KNEE ARTHROSCOPY, THE PRODUCT DID NOT CONDUCT ENERGY AT THE TIME OF CUTTING AND COAGULATION. IT WAS REPLACED WITH ANOTHER ONE WITH ANOTHER CODE AND DIFFERENT LOT, WHICH WORKED WITHOUT PROBLEM AND SURGERY WAS BEING ABLE TO PERFORM WITHOUT INCONVENIENCE FOR THE PATIENT AND FOR THE DOCTOR. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9246717 ↗
• MalfunctionOct 16, 2019Electrical Power Problem; Electrical Power Problem

  DEVICE REPORT FROM SYNTHES MITEK REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED BY THE AFFILIATE VIA PHONE THAT DURING A KNEE ARTHROSCOPY CLEANING THE VAPR P50 W/ HAND CONTROLS DOES NOT FUNCTION. THE PACKING OF THE DEVICE WAS OPENED, CONNECT THE GENERATOR, DOES NOT SHOW ANY ERROR CODE, BUT DID NOT WORK. CHANGED ANOTHER TWO DEVICES, THE EVENT RE-HAPPENED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE SURGERY TIME WAS NOT DELAYED. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS COMPLAINT IS FOR ONE (1) VAPR PREMIERE 50 ELECTRODE W/HAND CONTROLS, 3.0MM, 50° SUCTION W/INTEGRATED HANDPIECE. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9200557 ↗