Valleylab E1560Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884524000237), received between Jun 18, 2019 and Jul 25, 2023 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Melted” (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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 25, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LOOP ELECTROSURGICAL EXCISION PROCEDURE (LEEP), THE LOOP DISENGAGED FROM THE BASE ON ONE END, CAUSED A LACERATION IN THE VAGINA WITH BLEEDING OF 250CC. UNABLE TO VISUALIZE AS THERE WAS TOO MUCH BLEEDING. NO BLOOD TRANSFUSION REQUIRED. PROCEDURE WAS ABORTED. SURGEON HAD TO PACK THE VAGINA AND TRIED AGAIN. PATIENT WAS PACKED TWICE, AND ALSO HAD TRANEXAMIC ACID APPLIED TO CERVIX FOR HEMOSTASIS, AND HAD A FOLEY CATHETER INSERTED OVERNIGHT. PATIENT WAS SENT HOME AND THEN RETURNED TO CLINIC THE NEXT DAY TO BE EXAMINED. THERE WAS NO FURTHER BLEEDING WHEN PATIENT WAS ASSESSED THE FOLLOWING DAY. PATIENT WAS SCHEDULED TO HAVE HER LEEP IN SURGICAL DAYCARE ON (B)(6).

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s)

  MAUDE report 17389604 ↗
• MalfunctionDec 27, 2021Melted; Peeled/Delaminated; Melted; Peeled/Delaminated

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SURGEON USED POWER SETTING AT 40, AFTER 1-2 MINUTES, THE INSULATION MELTED. THE CUSTOMER WAS ADVISED TO USE ONLY AT MAXIMUM OF 30. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13087327 ↗
• MalfunctionAug 16, 2021Fire; Melted; Peeled/Delaminated; Fire; Melted; Peeled/Delaminated

  ACCORDING TO THE REPORTER, DURING A DEBULKING PROCEDURE (REMOVAL OF ALL TUMORS IN THE PERITONEUM CAVITY, WITH AN OVARIAN CANCER ORIGIN), THE DEVICE HAD A FIRE AND THE PLASTIC CONTOUR OF THE ELECTRODE HAS MELTED IN FULGURATE 80 ON COAGULATION MODE. THE EDGE OF THE ELECTRODE WAS OK BUT THE SURROUNDING OF IT WAS MELTED (THE BLUE PLASTIC). THE PICTURE ATTACHED SHOWED THAT THE DEVICE WAS BURNED AND MELTED. IT WAS HAPPENING ALL THE TIME BUT THIS WAS THE FIRST TIME THEY DID A MATERIOVIGILANCE. THEY STILL USED THE DEVICE EVEN IF IT WAS BURNED, BECAUSE IT HAPPENS ALL THE TIME DURING THE GESTURE OF THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12328180 ↗
• MalfunctionJul 27, 2021Melted; Peeled/Delaminated; Melted; Peeled/Delaminated

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE BALL ELECTRODE INSULATION MELTED AND IT PEELED OFF. THE MELTED INSULATION DID NOT FALL INTO PATIENT'S CAVITY HENCE NO BROKEN PIECE WAS RETRIEVED NOR AN X-RAY WAS PERFORMED. THERE WAS NO PATIENT INJURY. PHOTO SUBMITTED SHOWING BALL ELECTRODE INSULATION MELTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12231712 ↗
• InjuryJun 18, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING ELECTIVE LARGE LOOP EXCISION OF THE TRANSFORMATION ZONE (LLETZ) OF CERVIX, A SECTION OF THE LOOP WAS MISSING. THE REMAINS OF THE LOOP WAS NOT FOUND EVEN AFTER THOROUGH EXAMINATION OF THE VAGINA AND X-RAY OF THE PELVIX WAS PERFORMED.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 8709418 ↗