Microline 132-131DRecalls & reported problems
Microline Surgical, Inc. · TLS2 Thermal Ligating Shears Curved Jaw · 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
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00811099011439), received between Oct 25, 2018 and Oct 25, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (1 report).
1 FDA recall record name this device's identifier.
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.
Recalls naming this device
- Mar 22, 2019Terminated
The shears exhibited a high rate of complete or intermittent failure to actuate. As a result, they do not perform their intended function in surgical procedures.
Z-1698-2019 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Material Fragmentation1
Patient problems
- No Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 25, 2018Material Fragmentation; Material Fragmentation
DURING A SURGICAL PROCEDURE, A PIECE OF INSULATION BROKE OFF THE TLS3, THERMAL LIGATING SHEARS. THE PIECE COULD NOT BE RETRIEVED. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Information; No Known Impact Or Consequence To Patient
MAUDE report 8005354 ↗
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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 · each recall links to the FDA recall notice
- 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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