VAPR 225361Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10886705009381), received between Apr 24, 2018 and Sep 25, 2019 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Melted” (8 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2019Electrical /Electronic Property Problem; Electrical Power Problem; Electrical /Electronic Property Problem; Electrical Power Problem

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT AN ELECTRICAL FAILURE WAS SUSPECTED WITH THE VAPR 4.0 MM SUCT LOPROFILE PROBE DEVICE DURING AN UNSPECIFIED SURGERY. THERE WAS ONLY CLICKING SOUND ALTHOUGH THE SURGEON TAPPED THE FOOT SWITCH. THE SURGERY WAS FINISHED WITHOUT ANY OTHER PROBLEM ALTHOUGH IT WAS NOT REPORTED HOW THE SURGERY WAS COMPLETED. IT WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. THERE WAS NO HARM TO THE PATIENT. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE SURGICAL PROCEDURE OR IF 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 9117693 ↗
• MalfunctionJan 22, 2019Melted; Unexpected Shutdown; Suction Failure; Melted; Unexpected Shutdown; Suction Failure

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE SUCTION ON THE VAPR 4.0MM SUCT LOPROFILE DEVICE LOST OUTPUT POWER AFTER THREE MINUTES OF USE. ACCORDING TO THE REPORTER, THE DEVICE WAS BRAND NEW AND ITS FIRST USE WHEN THE ISSUE OCCURRED. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE AS AN IDENTICAL SPARE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 Consequences Or Impact To Patient

  MAUDE report 8268986 ↗
• MalfunctionJan 22, 2019Melted; Melted

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE VAPR 4.0MM SUCT LOPROFILE DEVICE DID NOT WORK WHEN ACTIVATED. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE AS AN IDENTICAL SPARE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 Consequences Or Impact To Patient

  MAUDE report 8267013 ↗
• MalfunctionJan 22, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED JOINT ARTHROSCOPE SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE VAPR 4.0MM SUCT LOPROFILE DEVICE BROKE. ACCORDING TO THE REPORTER, THE EVENT OCCURRED AFTER FIVE MINUTES THE SURGERY STARTED. IT WAS FURTHER REPORTED THAT THE CERAMIC PART BROKE; AND THE ALARM KEPT BEEPING. IT WAS REPORTED THAT THE SURGEON REPLACED IT WITH ANOTHER NEW SUCTION ELECTRODE. IT WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. THE BACKUP DEVICE WAS USED TO COMPLETE THE CASE. THE DEVICE WAS NOT BURIED IN TISSUE. IT WAS REPORTED THAT THE SURGERY WAS DELAYED FOR TEN MINUTES. IT WAS REPORTED THAT NOTHING FELL INTO THE PATIENT. 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 Consequences Or Impact To Patient

  MAUDE report 8266579 ↗
• MalfunctionOct 5, 2018Arcing of Electrodes; Sparking; Arcing of Electrodes; Sparking

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT AFTER ABOUT 20 MINUTES FROM THE START OF ASD DURING THE ARCR SURGERY, IT WAS OBSERVED THAT THERE WAS A WARNING SOUND AND THE SURGEON COULD NOT EXCISE THE TISSUE. WHEN THE SURGEON PULLED THE INSTRUMENT OUT FROM THE OPERATION FIELD, THERE WAS A SPARK FROM THE ELECTRODE WHILE EMITTING A WARNING SOUND WHEN THE SURGEON TAPPED THE FOOT SWITCH OF CUTTING. THERE WAS NO SPARK AND WARNING SOUND WHEN THE SURGEON TAPPED THE FOOT SWITCH OF HEMOSTAT. THE SURGERY WAS COMPLETED BY USING ALTERNATIVE PROBE (SAME P/N, BUT THE LOT# WAS UNKNOWN). IT WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE 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 Consequences Or Impact To Patient

  MAUDE report 7939062 ↗
• MalfunctionSep 24, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT RIGHT AFTER THE SURGEON STARTED USING THE SUCTION ELECTRODE, THE PATIENT¿S BODY TWITCHED. BECAUSE THE SURGEON BECAME ANXIOUS ABOUT SHORT CIRCUIT, HE REPLACED IT WITH A NEW LPS. AFTER THE REPLACEMENT, NO TWITCH WAS RECOGNIZED. THE HAND PIECE HAS BEEN IN USE FOR APPROXIMATELY FIVE TIMES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7903114 ↗
• MalfunctionSep 21, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ASPIRATION WAS DEFECTIVE WITH 2 ELECTRODES. USED 3RD ONE. NO PATIENT CONSEQUENCES. PLEASE SEE ALSO MEDWATCH REPORT 1221934-2018-52637.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7899506 ↗
• MalfunctionSep 21, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ASPIRATION WAS DEFECTIVE WITH 2 ELECTRODES. USED 3RD ONE. NO PATIENT CONSEQUENCES. PLEASE SEE ALSO MEDWATCH REPORT 1221934-2018-52638.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7899501 ↗
• MalfunctionSep 17, 2018Melted; Melted

  IT WAS REPORTED THAT THE PROBE TIP WAS DEFORMED LIKE MELTED DURING THE SURGERY ON (B)(6) 2018. THEN, THE SURGEON STOPPED USING THE REPORTED PROBE. THE SURGERY WAS COMPLETED BY USING ALTERNATIVE PROBE (SAME P/N, LOT NUMBER WAS UNKNOWN). IT WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7881953 ↗
• MalfunctionSep 13, 2018Melted; Melted

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A SHOULDER PROCEDURE, IT WAS OBSERVED THAT THE TIP VAPR PRESENTED A SHORT (BURNED) DURING ARTICULATION. THE PATIENT DID NOT PRESENT ANY SERIOUS EVENT. THE PROCEDURE WAS COMPLETED WITH SAME LIKE PRODUCT. THERE WAS A 15 MINUTE DELAY IN THE SURGICAL PROCEDURE. 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 Consequences Or Impact To Patient

  MAUDE report 7872764 ↗
• MalfunctionAug 16, 2018Melted; Melted

  IT WAS REPORTED THAT THE PRODUCT STOPPED WORKING SOON AFTER THE SURGERY HAD STARTED. IT SEEMED THAT THE TIP OF THE PROBE WAS BROKEN. WHEN THE PROBE WAS REPLACED TO ANOTHER PRODUCT AND CONNECTED TO THE SAME VAPR 3 SYSTEM, THERE WAS NO PROBLEM AND COMPLETED THE CASE. NOTHING WAS LEFT IN THE PATIENT. THE PROBE USED AT THE SURGERY WAS BRAND NEW DEVICE. THE SURGEON WAS EXPERT WITH THIS DEVICE AND THE INCIDENT WAS OCCURRED FOR THE FIRST TIME AT THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7789942 ↗
• MalfunctionAug 14, 2018Melted; Melted

  IT WAS REPORTED THAT DURING THE PROCEDURE THE RADIO FREQUENCY PRESENTED A FAILURE IN THE STERILE MATERIAL; THE CERAMIC MELTED DURING THE PROCEDURE. A NEW ONE HAD TO BE OPENED; THAT ONE DID NOT FAIL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7781851 ↗
• MalfunctionAug 3, 2018Break; Break

  IT WAS REPORTED THAT AT THE BEGINNING OF THE PROCEDURE, A PIECE OF THE CERAMIC RING BROKE AND THE DEVICE COULDN¿T WORK PROPERLY. IT WAS NOTED THE PHYSICIAN HAS USED THIS TYPE OF DEVICE FOR MANY YEARS. ADDITIONAL INFORMATION FROM THE AFFILIATE STATED THE PHARMACIST CONFIRMED NOTHING FELL INTO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7747838 ↗
• MalfunctionJul 25, 2018Sparking; Sparking

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE OUTPUT-ERROR ALARM CONTINUED DURING ROTATOR CUFF REPAIR SURGICAL PROCEDURE. THE SURGEON PUSHED THE FOOTSWITCH WITH THE DEVICE OUTSIDE THE PATIENT¿S BODY TO CHECK THE FUNCTIONALITY AND THE DEVICE SPARKED AT THE LATERAL SIDE. THE DEVICE WAS REPLACED BY THE SIDE EFFECT ELECTRODE WITH THE SAME HANDPIECE AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUE. THE DEVICE IN QUESTION WAS USED WITH VAPR3 WITH THE OUTPUT LEVELS AT CUTTING 180/COAGULATION 120. THERE WAS NO SURGICAL DELAY OR HARM TO THE PATIENT BECAUSE OF THIS PROBLEM. 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 Consequences Or Impact To Patient

  MAUDE report 7717996 ↗
• MalfunctionJul 19, 2018Melted; Melted

  IT WAS REPORTED BY OUR AFFILIATE THAT AN OUTPUT FAILURE OCCURRED WITH THE REPORTED DEVICE DURING ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2018. A METALLIC SOUND GAVE OFF ABOUT 15 MINUTES AFTER THE OPERATION WAS STARTED. WHEN TAKEN A LOOK AT CAREFULLY, IT WAS FOUND THAT THE ELECTRIC DETECTOR OF THE PROVE SEEMED TO BE BURNED. IT WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. THERE WAS NO DELAY IN SURGERY AND NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7702608 ↗
• MalfunctionJul 11, 2018Melted; Melted

  IT WAS REPORTED THAT THE DEVISE WAS USED FOR THE ARTHROSCOPIC ROTATOR CUFF REPAIR SURGERY TO REMOVE SOFT TISSUE OR STOP BLEEDING ON (B)(6) 2018. IT WAS REPORTED THAT THE PROBE COULD NOT FUNCTION SUDDENLY, SUCH AS SHORT-CIRCUITS (OUTPUT SHOTTED, 1 SEC RESET). THE SURGEON REPLACED THE PROBE (SAME P/N, LOT NUMBER WAS UNKNOWN) TO COMPLETE THE SURGERY. AFTER THE SURGERY, SURGEON NOTICED THAT THE PROBE TIP (CERAMIC COVER) WAS BROKEN. THE SURGEON CHECKED THE BROKEN FRAGMENT WHICH WAS SUSPECTED TO REMAIN THE PATIENT¿S BODY UNDER X-RAY, BUT THERE WERE NO BROKEN PARTS FOUND IN THE PATIENT¿S BODY. IT WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. THERE WAS LESS THAN 30MIN. SURGICAL DELAY AND NO HARM TO THE PATIENT.

  Patient problems: Not Applicable

  MAUDE report 7677608 ↗
• MalfunctionJun 5, 2018Suction Problem; Suction Problem

  IT WAS REPORTED BY OUR AFFILIATE THAT THE DEVICE COULD NOT PERFORM THE SUCTION DURING THE ARCR SURGERY ON (B)(6) 2018. THE SURGERY WAS FINISHED WITHOUT ANY OTHER PROBLEM ALTHOUGH IT WAS NOT REPORTED HOW THE SURGERY WAS COMPLETED. IT WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. THERE WAS LESS THAN 30 MIN. SURGICAL DELAY AND NO HARM TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient; Not Applicable

  MAUDE report 7570571 ↗
• MalfunctionMay 24, 2018Sparking; Sparking

  THE AFFILIATE REPORTED VIA EMAIL THAT THERE WAS AN ABNORMAL SPARK SCATTERED DURING ARTHROSCOPIC ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2017. IT WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. THE BACKUP DEVICE WAS USED TO COMPLETE THE CASE. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM THE AFFILIATE ON 10-24-2017. THE ISSUE WAS DETECTED DURING THE SURGERY: NO INFORMATION IS AVAILABLE IF THE ELECTRODE SPARKED INSIDE THE PATIENT. NO INFORMATION IS AVAILABLE HOW LONG THE ELECTRODE USED PRIOR TO THE SPARK. NO INFORMATION IS AVAILABLE IF ANYTHING FELL IN THE PATIENT. THERE WAS NO DELAY. THE PROCEDURE WAS ABLE TO BE COMPLETED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7539797 ↗
• MalfunctionApr 24, 2018Sparking; Sparking

  IT WAS REPORTED THAT AFTER THE PRODUCT HAS BEEN OPENED AND BEING USED DURING THE SURGERY, IT GENERATED TOO MANY SPARKS THAT MAKE IT IMPOSSIBLE TO USE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7455168 ↗