Valleylab E1563 (UDI 10887482196646)Recalls & reported problems
Aspen Surgical Products, Inc. · Private Label Medtronic Covidien 3mm Ball (5/box) · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887482196646), received between Mar 2, 2026 and Mar 2, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Melted” (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.
Reports received per month
Most reported problems
Device problems
- Melted1
- Peeled/Delaminated1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 2, 2026Melted; Peeled/Delaminated
IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALL TIP OF THE ELECTRODE MELTED DURING USE. THE DEVICE DID NOT BREAK DURING THE PROCEDURE AND DID NOT FALL INTO THE PATIENT CAVITY. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24479813 ↗
Other Electrocautery, Gynecologic (And Accessories) devices
- Enseal NSLX137CEthicon Endo-Surgery, LLC · ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)3 deaths344 reports
- ENSEAL X1 NSLX120LEthicon Endo-Surgery, LLC · ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)2 deaths172 reports
- Fischer Cone Biopsy Excisor 900-157Coopersurgical, Inc. · Electrocautery, Gynecologic (And Accessories)1 recall0 reports
- LEEP PRECISION™ Generator LP-20-120Coopersurgical, Inc. · Electrocautery, Gynecologic (And Accessories)45 reports
- Harmonic NSLX137SEthicon Endo-Surgery, LLC · ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)1 death19 reports
- LEEP PRECISION™ Integrated System LP-10-120Coopersurgical, Inc. · Electrocautery, Gynecologic (And Accessories)12 reports
- Fischer Cone Biopsy Excisor 900-151Coopersurgical, Inc. · Electrocautery, Gynecologic (And Accessories)10 reports
- AESCULAP PM438RAesculap AG · ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)7 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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