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PILLING IPN025440Recalls & reported problems

Teleflex Incorporated · Class 1

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 14026704658685), received between May 22, 2024 and May 22, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Thermal Decomposition of Device” (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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 1 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Thermal Decomposition of Device1

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.

  • MalfunctionMay 22, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

    IT WAS REPORTED THAT "DURING DIRECT LARYNGOSCOPY, WHILE USING THE PHILLING LIGHT CORD WHICH WAS PLUGGED INTO THE ARTHREX LIGHT SOURCE, STAFF IN THE OPERATING ROOM SMELLED A BURNING SMELL. SUBSEQUENTLY, WE REMOVED THE LIGHT CORD AND FOUND THAT THE TIP OF THE LIGHT CORD THAT ENTERS INTO THE LIGHT SOURCE HAD BEEN BURNT. THE TIP OF THE CORD WITH THE FIBERS WERE BURNT AS WELL.PATIENT SEEMED UNAFFECTED AND EQUIPMENT WAS TURNED OFF, REMOVED, AND TAGGED FOR FURTHER INVESTIGATION. SURGEON, PROCEEDED TO DO A VOCAL CORD LESION EXCISION, BY MICROSCOPE AND DID NOT SEE ANY HARM TO AIRWAY."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19374934 ↗

Other SOURCE, CARRIER, FIBEROPTIC LIGHT devices

All SOURCE, CARRIER, FIBEROPTIC LIGHT devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.