Valleylab E4057-CTRecalls & reported problems
Covidien LP · Bayonet Forceps,Gerald · Class 2
Data updated Oct 13, 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 10884524000794), received between Oct 8, 2019 and Oct 8, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Material Deformation1
- Peeled/Delaminated1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 8, 2019Peeled/Delaminated; Material Deformation; Peeled/Delaminated; Material Deformation
ACCORDING TO THE REPORTER, DURING SERVICING AT BIOMED, THE PENCIL HAD A SCRATCH ON THE SURFACE NEAR THE HANDLE. THE DEVICE FAILED ELECTRICAL SAFETY TEST AND HAD ELECTRIC LEAKAGE NEAR THE SCRATCH. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 9166767 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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