Valleylab E1564 (UDI 10884524000206)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884524000206), received between Nov 5, 2018 and Jun 9, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Melted” (4 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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2025Melted; Peeled/Delaminated; Melted; Peeled/Delaminated

  ACCORDING TO THE REPORTER DURING A LOOP ELECTROSURGICAL EXCISION PROCEDURE (LEEP), THE ELECTRODE HAD AN ISSUE. A NEW ELECTRODE WAS USED TO COMPLETE THE PROCEDURE. PHOTO WAS SUBMITTED SHOWING ELECTRODE INSULATION WAS DAMAGED AND MELTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22171791 ↗
• InjuryJan 20, 2023Melted; Peeled/Delaminated; Melted; Peeled/Delaminated

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE SHIELD ON THE ELECTRODE WAS MELTING. THE PATIENT HAD TISSUE DAMAGED OR UNEXPECTED TISSUE LOSS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16215877 ↗
• MalfunctionJan 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER THE CONE BIOPSY OF CERVIX: DILATION AND CURETTAGE, THE PHYSICIAN AND NURSE NOTICED THAT THE PATIENT DISCOVERED A BURN IN INNER VAGINAL WALL WHILE SURGERY STILL ONGOING. THICKENED MONSEL WAS APPLIED POST-OPERATIVELY TO BURN AREA. IT WAS NOTED THAT THE BURN WAS CAUSED BY THE INSULATION ELECTRODE BALL AND A COMPETITOR¿S DIATHERMY LOOP. ONLY THOSE TWO AND SPECULUM TOUCHED PATIENT INNER VAGINAL WALL.

  Patient problems: Burn(s)

  MAUDE report 13266076 ↗
• MalfunctionMar 18, 2021Melted; Detachment of Device or Device Component; Melted; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, PART OF THE DEVICE'S SHEATH MELTED INTO THE PATIENT'S TISSUE AND HAD TO BE RETRIEVED. DIATHERMY USED WAS 40/40, AFTER CONTINUOUS ACTIVATION SHEATH MELTED BUT WAS RETRIEVED USING FORCEPS AND NO X-RAY PROCEDURE WAS REQUIRED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11515825 ↗
• MalfunctionJul 22, 2020Peeled/Delaminated; Peeled/Delaminated

  ACCORDING TO THE REPORTER, DURING A CERVICAL ABLATION, WHILE USING THE DEVICE AT COAGULATION SETTING OF 50, THE SURGEON NOTICED THE APPEARANCE OF THE ELECTRODE WHEREIN THE COATING WAS MELTING. NOTHING FELL INTO THE PATIENT'S CAVITY. THEY DISCONTINUED USING THE ELECTRODE, AND REPLACED IT WITH A NEW ONE. THEY TURNED DOWN THE OUTPUT TO 40, AND CONTINUED THE CASE NORMALLY. BIOMED CHECKED OUTPUTS OF GENERATOR AND CONFIRMED THAT IT WAS WORKING CORRECTLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10306799 ↗
• MalfunctionNov 5, 2018Material Fragmentation; Melted; Peeled/Delaminated; Material Fragmentation; Melted; Peeled/Delaminated

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE'S INSULATION MELTED AND A PART OF THE DEVICE FELL ON THE PATIENT¿S CAVITY, BUT WAS FULLY RETRIEVED. THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8038791 ↗