Valleylab E1561Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884524000176), received between Jul 22, 2019 and May 8, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, THE LOOP BECAME UNATTACHED FROM THE ELECTRODE. THE SURGEON RETRIEVED BROKEN PIECE AND NO LOOP WAS LEFT IN THE PATIENT. USED ANOTHER DEVICE AND CONTINUED THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25123405 ↗
• MalfunctionJun 19, 2025Peeled/Delaminated; Arcing; Detachment of Device or Device Component; Peeled/Delaminated; Arcing; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING LOOP ELECTROSURGICAL EXCISION PROCEDURE (LEEP) PROCEDURE, THE LOOP ELECTRODE DETACHED ON ONE EDGE CAUSING A SPARK. NOTHING FELL INTO PATIENT'S CAVITY SO NO X-RAY OR ANY MEDICAL PROCEDURE WAS REQUIRED. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22289453 ↗
• MalfunctionOct 3, 2024Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE LOOP OF THE ELECTRODE BENT WHEN DOING A PASS THROUGH THE CERVIX. SURGICAL STAFF WERE UNABLE TO GET A CLEAN CUT CAUSING THE PATIENT TO BLEED MORE THAN USUAL FROM THE INCISION SITE. HEMOSTASIS WAS ACHIEVED WITH CAUTERIZATION OF THE CERVIX AND THE APPLICATION OF HEMOSTATIC AGENTS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20359191 ↗
• InjuryJul 22, 2019Material Fragmentation; Adverse Event Without Identified Device or Use Problem; Material Fragmentation; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A GYNECOLOGICAL PROCEDURE, THE CONE LOOP BROKE, THERE WAS SOMETHING FULLY DETACHED FROM THE DEVICE AND IT FELL INTO PATIENTS CAVITY BUT RETRIEVED. IT RESULTS TO A TEAR IN THE LATERAL CUL DE SAC RESULTING IN AN ACCIDENTAL WOUND.

  Patient problems: Tissue Damage

  MAUDE report 8814423 ↗