FMS 288022Recalls & reported problems

Summary

The FDA's MAUDE database contains 296 adverse event reports that list this exact device (DI 10886705018345), received between Dec 20, 2017 and Dec 11, 2023 — classified as 296 malfunctions.

The most frequently reported specific device problem is “Corroded” (46 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 25 most recent of 296 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN FRANCE THAT DURING AN UNKNOWN PROCEDURE ON 11/22/2023, IT WAS OBSERVED THAT THE HAND PC TORNADO SHAVER DEVICE WAS HOT DURING 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 18301216 ↗
• MalfunctionSep 5, 2023Device Contaminated During Manufacture or Shipping; Mechanical Jam; Device Contaminated During Manufacture or Shipping; Mechanical Jam

  IT WAS REPORTED BY THE SALES REP IN CZECH REPUBLIC THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023 , IT WAS OBSERVED THAT THE HAND PC TORNADO SHAVER DEVICE HAD A JAMMED MOTOR; AND THAT IT DID NOT TURN. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD FOREIGN DEBRIS/SUBSTANCE. 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 17684364 ↗
• MalfunctionMay 11, 2023Electrical /Electronic Property Problem; Mechanical Jam; Electrical /Electronic Property Problem; Mechanical Jam

  IT WAS REPORTED BY THE CUSTOMER IN HUNGARY THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE 8022 HANDPC TORNADO SHAVER DEVICE HAD A JAMMED MOTOR AS IT WAS NOT TURNING. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD A SHORT CIRCUIT IN THE CABLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16911541 ↗
• MalfunctionMar 2, 2023Electrical /Electronic Property Problem; Use of Device Problem; Electrical /Electronic Property Problem; Use of Device Problem

  THIS IS REPORT 2 OF 4 FOR (B)(4). IT WAS REPORTED BY THE AFFILIATE IN GREECE THAT DURING ROUTINE CHECK, IT WAS OBSERVED THAT THE HAND PC TORNADO SHAVER DEVICE DID NOT FUNCTION. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THERE WAS A SHORT CIRCUIT IN THE MOTOR CABLE ON THE DEVICE. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16471063 ↗
• MalfunctionNov 14, 2022Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE AFFILIATE IN POLAND THAT THE HAND PC TORNADO SHAVER DEVICE HAD AN UNSPECIFIED MALFUNCTION. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE FISHER CAP WAS BROKEN ON THE DEVICE. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15788651 ↗
• MalfunctionOct 31, 2022Mechanical Problem; Mechanical Jam; Mechanical Problem; Mechanical Jam

  IT WAS REPORTED BY THE SALES REP IN CZECH REPUBLIC THAT THE HAND PC TORNADO SHAVER DEVICE HAD A JAMMED MOTOR AND DID NOT TURN. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE LOCKING SYSTEM ON THE DEVICE WAS DAMAGED. 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 15700451 ↗
• MalfunctionJul 6, 2022Use of Device Problem; Device Contaminated During Manufacture or Shipping; Use of Device Problem; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED BY THE AFFILIATE IN RUSSIA THAT DURING SERVICE EVALUATION, IT WAS DETERMINED THAT THE HAND PC TORNADO SHAVER DEVICE HAD FOREIGN SUBSTANCE/DEBRIS. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14939925 ↗
• MalfunctionJun 3, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE SALES REP IN HUNGARY THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE MOTOR ON THE HANDPC TORNADO SHAVER DEVICE WAS JAMMED. 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 14597568 ↗
• MalfunctionApr 6, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED BY THE AFFILIATE IN GERMANY THAT THE 8022 HANDPC TORNADO SHAVER DEVICE DID NOT WORK. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE MOTOR WAS STICKING AND RUSTY AND THE CABLE RESISTANCE WAS OUT OF TOLERANCE; AND THAT THERE WAS AN ELECTRICAL SHORT. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14025704 ↗
• MalfunctionMar 29, 2022Electrical /Electronic Property Problem; Electrical Shorting; Mechanical Jam; Electrical /Electronic Property Problem; Electrical Shorting; Mechanical Jam

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE HANDPC TORNADO SHAVER DEVICE HAD A JAMMED MOTOR AND DID NOT TURN. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE 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 13940170 ↗
• MalfunctionJan 14, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED BY THE AFFILIATE IN ITALY THAT DURING SERVICE EVALUATION, IT WAS DETERMINED THAT THE 8022 HANDPC TORNADO SHAVER DEVICE FAILED THE ELECTRICAL SAFETY TEST. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13258536 ↗
• MalfunctionJan 14, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED BY THE AFFILIATE IN ITALY THAT DURING SERVICE EVALUATION, IT WAS DETERMINED THAT THE 8022 HANDPC TORNADO SHAVER DEVICE FAILED THE ELECTRICAL SAFETY TEST. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13258527 ↗
• MalfunctionJan 5, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE HANDPC TORNADO SHAVER DEVICE HAD A JAMMED MOTOR AND DID NOT TURN. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE FISHER CAP WAS BROKEN ON THE DEVICE. 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 13171877 ↗
• MalfunctionJan 5, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING SERVICE EVALUATION, IT WAS DETERMINED THAT THE HANDPC TORNADO SHAVER DEVICE FAILED THE ELECTRICAL SAFETY TEST. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13171786 ↗
• MalfunctionJan 5, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING SERVICE EVALUATION, IT WAS DETERMINED THAT THE HAND PC TORNADO SHAVER DEVICE FAILED THE ELECTRICAL SAFETY TEST. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13171703 ↗
• MalfunctionJan 5, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING SERVICE EVALUATION, IT WAS DETERMINED THAT THE HAND PC TORNADO SHAVER DEVICE FAILED THE ELECTRICAL SAFETY TEST. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13171596 ↗
• MalfunctionDec 27, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE 8022 HANDPC TORNADO SHAVER DEVICE DID NOT TURN - JAMMED MOTOR. DURING AN IN-HOUSE ENGINEERING EVALUATION OF A PHOTO PROVIDED BY THE CUSTOMER, IT WAS DETERMINED THAT THE ANCHOR WAS DEFORMED, AND STILL ATTACHED TO THE INSERTER VIA THE TENSIONED SUTURE. 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 13089708 ↗
• MalfunctionDec 13, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6). THAT DURING SERVICE EVALUATION, IT WAS DETERMINED THAT THE 8022 HANDPC TORNADO SHAVER DEVICE FAILED THE ELECTRICAL SAFETY TEST. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12987447 ↗
• MalfunctionDec 13, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED BY THE AFFILIATE IN BELGIUM THAT DURING SERVICE EVALUATION, IT WAS DETERMINED THAT THE 8022 HANDPC TORNADO SHAVER DEVICE FAILED THE ELECTRICAL SAFETY TEST. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12987429 ↗
• MalfunctionAug 20, 2021Mechanics Altered; Mechanics Altered

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE MOTOR ON THE HANDPC TORNADO SHAVER DEVICE WAS NOT WORKING. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE MOTOR ON THE DEVICE WAS CORRODED AND STICKING. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12348951 ↗
• MalfunctionAug 16, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT PREOPERATIVELY TO AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE HANDPC TORNADO SHAVER DEVICE HAD A JAMMED MOTOR THAT IT DID NOT TURN. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE MOTOR WAS CORRODED AND STICKING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. 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 12324786 ↗
• MalfunctionAug 3, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT THE HANDPC TORNADO SHAVER DEVICE HAD AN UNSPECIFIED MALFUNCTION. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE MOTOR WAS STICKING AND CORRODED. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12267218 ↗
• MalfunctionAug 2, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE CUSTOMER IN BELGIUM THAT THE HANDPC TORNADO SHAVER DEVICE HAD AN UNSPECIFIED MALFUNCTION. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE MOTOR ON THE DEVICE WAS STICKING AND CORRODED. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12259387 ↗
• MalfunctionAug 2, 2021Material Frayed; Mechanical Jam; Material Frayed; Mechanical Jam

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE HANDPC TORNADO SHAVER DEVICE DID NOT TURN AND HAD A JAMMED MOTOR. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE MOTOR WAS STICKING AND CORRODED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12259256 ↗
• MalfunctionAug 2, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE HANDPC TORNADO SHAVER DEVICE DID NOT TURN AND HAD A JAMMED MOTOR. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE MOTOR WAS STICKING AND CORRODED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12259228 ↗