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VAPR 228305Recalls & reported problems

Depuy Mitek, LLC · VAPR Hook Electrode with Hand Controls 3.5mm Hook Electrode with Integrated Handpiece · Class 2

All models of VAPR (30)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
7
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886705020928), received between Aug 21, 2018 and Aug 3, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 1 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 1 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 1 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 2 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break2
  • Electrical /Electronic Property Problem2
  • Appropriate Device Problem Term/Code Not Available1
  • Blocked Connection1
  • Device Damaged Prior to Use1
  • Output Problem1
  • Physical Resistance/Sticking1
  • Suction Failure1

Patient problems

  • No Clinical Signs, Symptoms or Conditions5
  • Impaired Healing1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 3, 2026Break

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50114106 ↗
  • MalfunctionAug 3, 2026Break

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50113922 ↗
  • MalfunctionNov 14, 2025Electrical /Electronic Property Problem; Physical Resistance/Sticking; Electrical /Electronic Property Problem; Physical Resistance/Sticking

    IT WAS REPORTED THAT DURING AN ARTHROSCOPIC PROCEDURE OF THE KNEE, WHILE USING A VAPR HOOK W/ HAND CONTROLS DEVICE, IT WAS OBSERVED THAT THE COAGULATION WAS NOT WORKING WHEN THE BUTTON WAS PRESSED. IT WAS REPORTED THAT ANOTHER DEVICE WAS USED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO SURGICAL DELAYS AND NO HARM TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23554765 ↗
  • MalfunctionJun 17, 2025Electrical /Electronic Property Problem; Use of Device Problem; Device Damaged Prior to Use; Electrical /Electronic Property Problem; Use of Device Problem; Device Damaged Prior to Use

    IT WAS REPORTED THAT THE VAPR HOOK W/ HAND CONTROLS DEVICE ELECTRODE WAS DEFECTIVE OUT OF THE BOX. COAGULATION AND THE BLADE DID NOT WORK. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22236730 ↗
  • MalfunctionAug 28, 2024Blocked Connection; Output Problem; Blocked Connection; Output Problem

    IT WAS REPORTED BY THE SALES REP IN GERMANY THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON AN UNKNOWN DATE THE CUSTOMER'S VAPR NO LONGER RECOGNIZED THIS ELECTRODE AND SHOWED THE ERROR MESSAGE ¿FAULTY INSTRUMENT¿ ON THE DISPLAY. ACCORDING TO THE REPORTER THE CUSTOMER DISCONNECTED AND RECONNECTED THE ELECTRODE DURING THE OPERATION AND WAS ABLE TO CONTINUE OPERATING UNTIL THE ERROR OCCURRED AGAIN. IT WAS REPORTED THAT THE ELECTRODE HAD TO BE DISCONNECTED AND RECONNECTED SEVERAL TIMES DURING THE OPERATION. THERE WAS NO SIGNIFICANT 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 20083239 ↗
  • InjuryOct 6, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE PATIENT HAD WOUND HEALING DISORDER AFTER USING VAPR HOOK W/ HAND CONTROLS ELECTRODE DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE STATUS OF THE PATIENT POST-SURGERY WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: Impaired Healing

    MAUDE report 12584124 ↗
  • MalfunctionAug 21, 2018Suction Failure; Suction Failure

    IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ANKLE RECONSTRUCTION THE CUSTOMER'S VAPR HOOK ELECTRODE WITH HAND CONTROLS WOULD NOT COAGULATE. THE SALES REP STATED THAT THE GENERATOR WAS ON THE DEFAULT SETTING AND THE ELECTRODE IS BRAND NEW AND NOT RE-PROCESSED. THE SALES REP STATED THAT THE ABLATION FEATURE WAS WORKING. THE PROCEDURE WAS COMPLETED WITH A LIKE-DEVICE FROM THE SAME LOT NUMBER WITH NO HARM TO THE PATIENT OR DELAYS TO THE CASE. THE DEVICE IS BEING RETURNED FOR EVALUATION.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7801666 ↗

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Sources and updates

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