VAPR 227355Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886705009732), received between May 7, 2019 and Sep 15, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (3 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50776985 ↗
• MalfunctionJun 5, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGERY, THE METAL PIECE OF THE VAPR ELECTRODE FELL OFF. IT WAS REMOVED FROM THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25406190 ↗
• MalfunctionMay 4, 2026Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING AN ACL (ANTERIOR CRUCIATE LIGAMENT) REPAIR WITH A S50 SM.DIA.ELECTRODE W/INTEG.HNDPIECE-EA, THE DEVICE GENERATED SPARKS. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS A 5 MIN DELAY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25067677 ↗
• MalfunctionFeb 17, 2026Device Damaged Prior to Receipt by User

  IT WAS REPORTED THAT DURING A MENISCAL REPAIR SURGERY THE METAL PORTION OF THE S50 SM.DIA.ELECTRODE W/INTEG.HNDPIECE TIP HAD PEELED OFF WHEN THE PACKAGING WAS OPENED. THE DEVICE WAS NOT USED. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE. IT WAS REPORTED THAT A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY. 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 24367833 ↗
• MalfunctionDec 10, 2025Break; Electrical /Electronic Property Problem; Break; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING A SHOULDER JOINT CLEANING SURGICAL PROCEDURE, WHILE USING THE VAPR S50 SM.DIA.ELECTRODE W/INTEG.HNDPIECE DEVICE, IT WAS OBSERVED THAT METAL SHAVINGS OF THE BLADE FELL OFF, ACCOMPANIED BY SPARKS. 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 23770991 ↗
• MalfunctionAug 30, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE S50 3MM/50º SUCTION ELECTRODE W/ INTEGRATED HANDPIECE DEVICE HAD NO SUCTION WHEN CONNECTED TO THE ASPIRATOR INSIDE THE ARTICULAR CAVITY; AND THAT EVEN BACK FLUSHING WITH A SYRINGE STILL DID NOT WORK. 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 17650809 ↗
• MalfunctionJun 8, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED BY THE CUSTOMER IN CHINA THAT DURING A MENISCAL REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE STERILIZATION EFFECT ON THE S50 3MM/50º SUCTION ELECTRODE W/ INTEGRATED HANDPIECE DEVICE WAS POOR. 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 14632680 ↗
• MalfunctionJan 10, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN ARTHROSCOPIC SHOULDER STABILIZATION SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE S50 SM.DIA.ELECTRODE W/INTEG.HNDPIECE DEVICE WOULD NOT COAGULATE. 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 13207279 ↗
• MalfunctionDec 21, 2021Use of Device Problem; Use of Device Problem

  IT WAS BY THE AFFILIATE IN (B)(6) THAT DURING A ROTATOR CUFF REPAIR PROCEDURE AND AFTER CONNECTING TO THE GENERATOR, THE 50 SM.DIA.ELECTRODE W/INTEG.HNDPIECE-EA DEVICE DID NOT FUNCTION AT ALL AND THE SCREEN DID NOT SHOW ANY ALERT CODE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE COAGULATION AND ABLATION MODE HAD FAILED. 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 13053808 ↗
• MalfunctionDec 4, 2020Blocked Connection; Blocked Connection

  IT WAS REPORTED VIA COMPLAINT SUBMISSION TOOL THAT DURING AN UNKNOWN PROCEDURE WHILE USING A S50 3MM/50º SUCTION ELECTRODE W/ INTEGRATED HANDPIECE, CONNECTION DID NOT WORK CORRECTLY. THERE WAS A SURGICAL DELAY OF 5 MINUTES AND NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED THE EVENT OCCURRED INTRA-OPERATIVELY AND THE CASE WAS COMPLETED WITH ANOTHER READILY AVAILABLE ELECTRODE. IT WAS REPORTED THE DELAY DID NOT CAUSE PATIENT HARM AND SURGICAL INTERVENTION WAS NOT REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10944720 ↗
• MalfunctionSep 30, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED BY SALES REP VIA COMPLAINT SUBMISSION TOOL THAT DURING A KNEE ARTHROSCOPY, WHEN CONNECTING A S50 3MM/50º SUCTION ELECTRODE W/ INTEGRATED HANDPIECE TO THE GENERATOR IT DOES NOT FUNCTION AT ALL (COULD NOT COAGULATE AND CUT). ANOTHER DEVICE WAS USED TO COMPLETE PROCEDURE. NO SURGICAL DELAY OR PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10605048 ↗
• MalfunctionMay 7, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN PROCEDURE THE BLADE DID NOT FUNCTION. THE PROCEDURE WAS COMPLETED WITH A SECOND BLADE WITH NO HARM TO THE PATIENT. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE SUCTION TUBE ON THE DEVICE HAD RESIDUE. IT WAS FURTHER DETERMINED THAT THE DEVICE DID NOT ABLATE NOR COAGULATE. 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 8585922 ↗