Valleylab E3310 (UDI 20884521039091)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 20884521039091), received between Oct 2, 2019 and Aug 5, 2024 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, FOUR-YEAR-OLD FEMALE UNDERWENT PROCEDURE-BILATERAL MYRINGOTOMY TUBES AND ADENOIDECTOMY, THE PROCEDURE WENT WELL. SURGICAL TECHNOLOGIST TRIED TO SUCTION SALINE OFF FACE, ACCIDENTALLY HIT CAUTERY BUTTON VS. SUCTION ON BOVIE RESULTING TO SUPERFICIAL BURN INSIDE OF THE EYELID AND BURN TWICE THE NOSE.

  Patient problems: Burn(s)

  MAUDE report 19913115 ↗
• MalfunctionJun 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY ON EAR, NOSE AND THROAT (ENT) PROCEDURE, THE PATIENT HAD BURN ON ONSIDE CREASE OF MOUTH.

  Patient problems: Burn(s)

  MAUDE report 19550553 ↗
• MalfunctionJan 19, 2024Failure to Deliver Energy; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Failure to Deliver Energy; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  ACCORDING TO THE REPORTER, DURING ADENOIDECTOMY, THE DEVICE APPEARED TO COAGULATE POORLY, POSSIBLY CAUSING ADDITIONAL BLEEDING OF LESS THAN 250CC. NO BLOOD TRANSFUSION REQUIRED. AFTER REPLACING A NEW SIMILAR SUCTION COMBUSTION INSTRUMENT, IT WORKED FLAWLESSLY AND THE LEAK WAS QUICKLY STOPPED. VISUALLY, THE METAL TIP OF THE BURNER LOOKED DIFFERENT IN SIZE, LIKE ANOTHER SIMILAR SUCTION BURNER.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18548072 ↗
• MalfunctionApr 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, UPON TESTING FOR SINUS CASE, THE SUCTION TIP WAS SEVERED AT THE BASE GOING TO HANDPIECE. RESOLUTION WAS NEW ONE.

  Patient problems: Insufficient Information

  MAUDE report 16828286 ↗
• InjuryMar 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THERE WAS NO ISSUE NOTED DURING THE INITIAL CASE. THE PATIENT WAS BROUGHT BACK THE NEXT DAY FOR RE OPERATION OR ADDITIONAL SURGERY TO RE COAGULATE AS THEIR TONSILS STARTED TO BLEED IN POST OP AND HAD TO BE BROUGHT BACK TO RE COAGULATE. THERE WAS NO INTRA OPERATIVE ABNORMALITY NOTED IN THE OPERATIVE NOTES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16485210 ↗
• InjuryMar 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER A PROCEDURE, THE PATIENT WAS BROUGHT BACK AS THEIR TONSILS STARTED TO BLEED. NO ISSUE WAS NOTED DURING THE CASE. HAD TO BE BROUGHT BACK TO RE COAGULATE. ALL THREE LED TO A RETURN TO SURGERY FOR HEMORRHAGIC TONSILS. NO INTRAOPERATIVE ABNORMALITY WAS NOTED ON OPERATIVE NOTES. THERE WAS A BLEEDING BUT TRANSFUSION WAS NOT REQUIRED, AMOUNT OF BLOOD LOSS WAS NOT SPECIFIED. MEDICAL OR SURGICAL INTERVENTION NEEDED. EXTENDED PATIENT'S HOSPITALIZATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16482559 ↗
• InjuryMar 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER PROCEDURE, PATIENT WAS ADMITTED DUE TO HEMATEMESIS AND DYSPNEA. COMPETITOR¿S GENERATOR UTILIZED SETTING AT 15. PATIENT HAD BLEEDING AND FOUR (4) UNITS PACKED RED BLOOD CELLS (PRBC) AND ONE (1) UNIT OF FRESH FROZEN PLASMA (FFP) WERE ADMINISTERED DURING HOSPITALIZATION. THE PATIENT WAS BROUGHT BACK TO OR FOR RE-OPERATION WITH SUCTION COAGULATOR ON COMPETITOR¿S GENERATOR WITH SETTING AT 15 AS THE PATIENT HAD HEMORRHAGIC TONSILS AND NEED TO RE-COAGULATE. NO INTRAOPERATIVE ABNORMALITY NOTED ON OPERATIVE NOTES. PATIENT NEEDED MEDICAL OR SURGICAL INTERVENTION AND HOSPITALIZATION WAS EXTENDED. HOME MEDICATION LIST INCLUDES TRAZODONE AND RISPERIDONE FOR BEHAVIORAL CONCERNS WERE PRESCRIBED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16479726 ↗
• InjuryMay 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A TONSILLECTOMY AND ADENOIDECTOMY PROCEDURE, THE PATIENT HAD A BURNED TISSUE FROM BOTH SIDES OF THE MOUTH/LIPS. THE BURN WAS TREATED WITH SURGICAL REPAIR. THE INJURY WAS DISCOVERED AT THE CONCLUSION OF THE CASE WHEN ALL DEVICES AND RETRACTORS WERE REMOVED FROM THE PATIENT. THE CAUSE OF INJURY WAS UNKNOWN AT THIS TIME. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Burn(s)

  MAUDE report 11760102 ↗
• MalfunctionOct 2, 2019Fire; Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, DEVICE DISTAL TIP HAD A FLAME. PRODUCT WAS IMMEDIATELY REMOVED FROM THE SURGICAL FIELD AND A NEW DEVICE WAS OPENED AND USED WITH NO ISSUES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9149340 ↗