SPRAY CATHETER PW-6C-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170062391), received between Oct 5, 2023 and Oct 5, 2023 — classified as 1 injury.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "CLOSE-TO-LESION TRANSBRONCHIAL BIOPSY: A NOVEL TECHNIQUE TO IMPROVE SUITABILITY OF SPECIMENS FOR GENETIC TESTING IN PATIENTS WITH PERIPHERAL PULMONARY LESIONS". LITERATURE SUMMARY BRONCHOSCOPY WITH RADIAL-PROBE ENDOBRONCHIAL ULTRASOUND, A GUIDE SHEATH, AND ELECTROMAGNETIC NAVIGATION CAN IMPROVE THE DIAGNOSTIC YIELD OF PERIPHERAL LUNG NODULES. HOWEVER, THE SUITABILITY OF SPECIMENS FOR GENETIC ANALYSIS REMAINS UNSATISFACTORY. WE HYPOTHESIZED THAT A TRANSBRONCHIAL BIOPSY PERFORMED AFTER CLOSELY APPROACHING THE BRONCHOSCOPE TIP TO THE LESION MIGHT PROVIDE MORE SUITABLE SPECIMENS FOR GENETIC ANALYSIS. WE ENROLLED 155 PATIENTS WITH PERIPHERAL PULMONARY LESIONS WHO UNDERWENT BRONCHOSCOPY WITH A THIN OR ULTRATHIN BRONCHOSCOPE. BRONCHOSCOPY WAS PERFORMED USING VIRTUAL BRONCHOSCOPIC NAVIGATION AND RADIAL-PROBE ENDOBRONCHIAL ULTRASOUND WITH A GUIDE SHEATH. THE BRONCHOSCOPE TIP WAS PLACED CLOSER TO THE LESION DURING BRONCHOSCOPY TO COLLECT LARGER SPECIMENS WITH HIGHER MALIGNANT CELL CONTENT. THE PATIENTS WHO UNDERWENT A CLOSE-TO-LESION BIOPSY HAD HIGHER RATES OF OVERALL DIAGNOSTIC YIELD, HISTOPATHOLOGICAL DIAGNOSTIC YIELD, AND

  Patient problems: Decreased Appetite; Low Oxygen Saturation; Pneumonia

  MAUDE report 17878789 ↗