VAPR COOLPULSE 225031Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10886705027958), received between Oct 17, 2019 and Feb 10, 2026 — classified as 1 injury, 26 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (7 reports).

1 other recall cover devices cleared under the same FDA submission (K143475); 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 18, 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.

• MalfunctionFeb 10, 2026Electrical /Electronic Property Problem

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, TWO COOLPULSE CURVE DEVICES WERE NOT COAGULATING FAST ENOUGH WITH THE ELECTRODES FOR THE PAST MONTH. ACCORDING TO THE REPORTER, THE CONSOLE WAS EXCHANGED AND DIFFERENT BATCH NUMBERS WERE TRIED WITHOUT SUCCESS, AND THERE WERE NO ISSUES WITH THE CONSOLE'S SCREEN TRACKING. IT WAS REPORTED THAT FUNCTIONING WAS OKAY WITH THE HOOKS. THE PROCEDURE WAS DELAYED, THOUGH THE EXACT DURATION OF THE DELAY WAS NOT SPECIFIED. 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 JANUARY 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24307843 ↗
• MalfunctionFeb 10, 2026Electrical /Electronic Property Problem

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, TWO COOLPULSE CURVE DEVICES WERE NOT COAGULATING FAST ENOUGH WITH THE ELECTRODES FOR THE PAST MONTH. ACCORDING TO THE REPORTER, THE CONSOLE WAS EXCHANGED AND DIFFERENT BATCH NUMBERS WERE TRIED WITHOUT SUCCESS, AND THERE WERE NO ISSUES WITH THE CONSOLE'S SCREEN TRACKING. IT WAS REPORTED THAT FUNCTIONING WAS OKAY WITH THE HOOKS. THE PROCEDURE WAS DELAYED, THOUGH THE EXACT DURATION OF THE DELAY WAS NOT SPECIFIED. 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 JANUARY 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24307835 ↗
• MalfunctionFeb 10, 2026Electrical /Electronic Property Problem; Power Problem

  THIS IS REPORT 2 OF 2 OF (B)(4). IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT WHILE USING 2X COOLPULSE CURVE DEVICES, COAGULATION WAS NOT FAST ENOUGH WITH ELECTRODES FOR ONE MONTH. THE OPERATION WAS OKAY WITH HOOKS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS AN UNSPECIFIED DELAY TO THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2026. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24307530 ↗
• MalfunctionFeb 10, 2026Electrical /Electronic Property Problem; Power Problem

  THIS IS REPORT 1 OF 2 OF (B)(4). IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT WHILE USING 2X COOLPULSE CURVE DEVICES, COAGULATION WAS NOT FAST ENOUGH WITH ELECTRODES FOR ONE MONTH. THE OPERATION WAS OKAY WITH HOOKS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS AN UNSPECIFIED DELAY TO THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2026. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24307360 ↗
• MalfunctionSep 11, 2025Misconnection; Blocked Connection; Output Problem; Misconnection; Blocked Connection; Output Problem

  IT WAS REPORTED THAT DURING A HIP LABRUM REPAIR ON HIP JOINT PROCEDURE, AN ATTEMPT WAS MADE TO CONNECT A COOLPULSE CURVE DEVICE TO THE VAPR VUE GENERATOR DEVICE AND USE WAS ATTEMPTED, BUT THE MESSAGE "INVALID" WAS DISPLAYED AND THE COOLPULSE CURVE WAS NOT CONNECTED. IT WAS REPORTED THAT THE POWER WAS SWITCHED OFF AND ON, THE COOLPULSE CURVE WAS LOADED AND BECAME USABLE FOR AWHILE, BUT AFTER JUST A FEW SECONDS OF OPERATING THE FOOT SWITCH, THE DISPLAY IMMEDIATELY CHANGED TO "INVALID" AND THE CONNECTION BECAME IMPOSSIBLE. FURTHER ATTEMPTS WERE MADE TO POWER THE DEVICE OFF AND ON, BUT THE COOLPULSE CURVE STILL DID NOT CONNECT PROPERLY. AS THE SURGERY COULD NOT BE CONTINUED, A DIFFERENT TYPE OF HANDPIECE PROBE WAS TRIED AND WAS ABLE TO CONNECT WITHOUT ANY PROBLEMS. THE SURGERY CONTINUED USING THIS AND WAS COMPLETED WITHOUT FURTHER PROBLEMS. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23025392 ↗
• MalfunctionSep 9, 2025Device Remains Activated; Mechanical Jam; Device Remains Activated; Mechanical Jam

  IT WAS REPORTED THAT DURING A HIGH TIBIAL OSTEOTOMY (HTO) AND MEDIAL MENISCUS POSTERIOR ROOT TEAR (MMPRT) ON KNEE FOR OSTEOARTHRITIS (OA) AND MENISCUS POSTERIOR ROOT TEAR, WHILE USING THE COOLPULSE CURVE DEVICE, THE HEMOSTATIC MODE SUDDENLY TURNED ON EVEN THOUGH THE FOOT SWITCH OR HAND CONTROL WAS NOT PRESSED. THE CORD WAS UNPLUGGED, THE UNIT WAS TURNED BACK ON, AND WHEN IT WAS PLUGGED BACK IN, THE DISPLAY SHOWED SOMETHING LIKE "¿ STUCK ." SEVERAL ATTEMPTS WERE MADE TO UNPLUG AND PLUG THE CORD BACK IN, HOWEVER THIS DID NOT IMPROVE THE SITUATION. A NEW DEVICE WAS OPENED AND TESTED, WHICH WORKED WITHOUT ANY PROBLEM. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23004973 ↗
• MalfunctionJul 25, 2025Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) SURGICAL PROCEDURE IT WAS OBSERVED THAT THE COOLPULSE CURVE DEVICE SUCTION DID NOT WORK IMMEDIATELY AFTER THE USER STARTED TO USE THE DEVICE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22612390 ↗
• MalfunctionMay 29, 2025Infusion or Flow Problem; Output Problem; Infusion or Flow Problem; Output Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, IT WAS OBSERVED THAT FIVE MINUTES AFTER STARTING TO USE THE COOLPULSE CURVE DEVICE, THE SUCTION STOPPED WORKING AND IT COULD NOT BE USED. 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 22104736 ↗
• MalfunctionMay 21, 2025Output Problem; Output Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS FOUND THAT THE ALARM ON THE COOLPULSE CURVE DEVICE WAS FREQUENTLY SOUNDING AND THEN IT STOPPED OUTPUTTING ENTIRELY. AFTER SWITCHING TO A DIFFERENT PROBE, THE DEVICE OPERATED WITHOUT ANY ISSUES, SUGGESTING THAT THE PROBLEM LIES WITH THE ORIGINAL PROBE. IT WAS NOT REPORTED IF THERE WERE ANY 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 22061347 ↗
• MalfunctionSep 11, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED FROM JAPAN THAT PREOPERATIVELY TO AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE TIP ON THE COOLPULSE CURVE DEVICE WAS WAS CLEARLY DIRTY UPON OPENING. THERE WERE NO DELAYS IN THE SURGICAL PROCEDURE AS AN IDENTICAL SPARE DEVICE WAS AVAILABLE FOR USE. 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 20191209 ↗
• MalfunctionJun 3, 2024Device Remains Activated; Physical Resistance/Sticking; Device Remains Activated; Physical Resistance/Sticking

  IT WAS REPORTED BY A DISTRIBUTOR IN MALAYSIA THAT DURING A (ACL) ANTERIOR CRUCIATE LIGAMENT AND MENISCUS REPAIR SURGICAL PROCEDURE ON AN UNKNOWN DATE THE COOLPULSE CURVE DEVICE HAD ISSUES HALFWAY THROUGH THE CASE. IT WAS STUCK AT COAGULATION NO MATTER WHICH HANDPIECE BUTTON WAS PRESSED. AND AT TIMES, COAGULATION WOULD BE ACTIVATED EVEN WHEN THE BUTTONS WERE NOT PRESSED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19453573 ↗
• MalfunctionMay 2, 2024Device Remains Activated; Physical Resistance/Sticking; Device Remains Activated; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A SHOULDER SCOPE PROCEDURE, IT WAS OBSERVED THAT THE COOL PULSE CURVE DEVICE WOULD STILL ABLATE EVEN WHEN THE BUTTON HAD BEEN RELEASED. IT WAS REPORTED THAT THE ONLY WAY TO PREVENT THE WAND FROM CONTINUING TO ABLATE WAS TO DISCONNECT IT FROM THE GENERATOR. THEY TRIED TURNING OFF THE GENERATOR AND TURNING IT BACK ON AND THE PROBLEM STILL EXISTED. 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 19229613 ↗
• MalfunctionApr 25, 2024Mechanical Problem; Blocked Connection; Mechanical Problem; Blocked Connection

  IT WAS REPORTED FROM JAPAN THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE COOLPULSE CURVE DEVICE DID NOT RESPOND AND HAD POOR CONNECTION. THE SURGERY WAS COMPLETED WITH SHAVER ONLY, WITHOUT RF. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19183658 ↗
• MalfunctionAug 7, 2023Infusion or Flow Problem; Infusion or Flow Problem

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN SWITZERLAND THAT DURING A HIP SCOPE PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE VAPR COOLPULSE CURVE SUCTION ELECTRODE DEVICE CLOGGED-UP, AND THUS BLOCKING THE SUCTION AFTER AROUND 10 MINUTES OF USE. CHANGED TO ANOTHER ONE TO CONTINUE THE PROCEDURE BUT CLOGGED-UP THE FIRST TIME AFTER 5 TO 10 MINUTES OF USE. 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 17474717 ↗
• MalfunctionAug 1, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE VAPR COOLPULSE CURVE SUCTION ELECTRODE DEVICE HAD AN IGNITION OCCURRED FROM BETWEEN THE WHITE PART OF THE DEVICE AND THE ELECTRODE PART. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITHIN 30 MINUTES DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17437746 ↗
• MalfunctionJan 19, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED BY THE SALES REP IN CHILE THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE COAGULATION ON THE VAPR COOLPULSE CURVE SUCTION ELECTRODE DEVICE DID NOT WORK BUT ONLY CUTTING. IT WAS UNKNOWN IF AND HOW 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 16210412 ↗
• MalfunctionOct 19, 2022Use of Device Problem; Output Problem; Use of Device Problem; Output Problem

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT EARLY ON, THE VAPR COOLPULSE CURVE SUCTION ELECTRODE DEVICE WAS FUNCTIONAL, BUT THE DEVICE'S ABLATION AND COAGULATION FUNCTIONS SUDDENLY BECAME UNUSABLE. ACCORDING TO THE REPORT, THERE WAS A POSSIBILITY THAT THE TIP OF THE DEVICE CONTINUED TO HIT THE METAL OF THE TKA IMPLANTS AND CAUSED SHORT-CIRCUIT BECAUSE THE DEVICE WAS USED FOR DEBRIDEMENT DUE TO INFECTION AFTER TKA. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15633565 ↗
• MalfunctionOct 12, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED BY THE SALES REP IN SWITZERLAND THAT DURING AN UNKNOWN SURGERY ON (B)(6)2022, IT WAS OBSERVED THAT THE VAPR COOLPULSE CURVE SUCTION ELECTRODE DEVICE WAS CLOGGED. 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 15587567 ↗
• MalfunctionAug 8, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING A MENISCAL REPAIR PROCEDURE OF THE RIGHT KNEE ON (B)(6) 2022, IT WAS OBSERVED THAT THE SUCTION FEATURE ON THE VAPR COOLPULSE CURVE SUCTION ELECTRODE DEVICE WAS OUT OF ORDER SOON AFTER THE PROCEDURE STARTED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH LESS THAN 30-MINUTE SURGICAL DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15186673 ↗
• MalfunctionJun 8, 2022Output Problem; Output Problem

  IT WAS REPORTED BY THE SALES REP IN UNITED KINGDOM THAT DURING A KNEE ARTHROSCOPY PROCEDURE ON (B)(6) 2022 FOR THE ABLATION OF THE DEGENERATE MENISCUS, IT WAS OBSERVED THAT THE VAPR COOLPULSE CURVE SUCTION ELECTRODE DEVICE STOPPED WORKING AFTER A FEW MINUTES OF IT WORKING. 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 14634571 ↗
• MalfunctionMar 10, 2022Blocked Connection; Blocked Connection

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE COOLPULSE CURVE DEVICE WAS UNABLE TO CONNECT TO THE GENERATOR. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 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 13722228 ↗
• MalfunctionJun 22, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE SUCTION ON THE VAPR COOLPULSE CURVE SUCTION ELECTRODE DEVICE WAS BLOCKED BEFORE THE DEVICE WAS IN-SITU. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF THREE MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12043008 ↗
• MalfunctionMar 31, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ARTHROSCOPIC SYNOVECTOMY ON (B)(6) 2021, IT WAS OBSERVED THAT THE SUCTION FEATURE ON THE ELECTRODE DEVICE BECAME OUT OF ORDER. THE PROCEDURE WAS COMPLETED. THERE WAS NO SURGICAL DELAY NOR ADVERSE PATIENT CONSEQUENCES REPORTED. THE DEVICE WAS BRAND NEW AND ITS FIRST USE WHEN THE ISSUE OCCURRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11597291 ↗
• MalfunctionNov 24, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED BY THE AFFILIATE IN GERMANY THAT DURING A HIP ARTHROSCOPY PROCEDURE ON (B)(6) 2020, IT WAS OBSERVED THAT THE COAGULATION FUNCTIONALITY ON THE VAPR COOLPULSE CURVE DEVICE WAS NOT WORKING. ACCORDING TO THE REPORT, THE SUCTION OF THE ELECTRODE WAS FINE BUT BOTH ABLATION AND COAGULATION DID NOT WORK. THERE WAS A TWO MINUTE DELAY IN THE PROCEDURE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10895504 ↗
• MalfunctionJan 30, 2020Suction Failure; Suction Failure

  IT WAS REPORTED BY THE AFFILIATE VIA COMPLAINT SUBMISSION TOOL THAT DURING AN UNKNOWN PROCEDURE THE COOLPULSE CURVE SUCTION BLOCKED. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9650368 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K143475. One submission often covers many models, so check the product and lot details in each record.

• Z-0479-2016 · Nov 23, 2015 · Terminated
  VAPR TRIPOLAR 90" Degree Suction Electrodes (Model/Catalog No: 225028)