WAYNE PNEUMOTHORAX TRAY
Received Jun 10, 2026
Report 1820334-2026-00611 · MDR key 25462468
Device
Product problems
- Unraveled Material
Patient
NA · Unknown
- Insufficient Information
Narrative
Additional Manufacturer Narrative
G4 ¿ PMA/510(K) #: EXEMPT. H3 - DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
Description of Event or Problem
IT WAS REPORTED THAT THE WIRE GUIDE INCLUDED IN A WAYNE PNEUMOTHORAX TRAY UNRAVELED DURING A ROBOTIC-ASSISTED BRONCHOSCOPY FOR AN UNKNOWN PATIENT. THE PATIENT DEVELOPED A PNEUMOTHORAX DURING THIS PROCEDURE; HOWEVER, THIS WAS SAID TO BE UNRELATED TO THE UNRAVELED WIRE GUIDE ISSUE. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.