FIVE S 3.5X65, STERILE, FOR SINGLE USE,

Additional Manufacturer Narrative

THE DEVICE WAS USED AND CONTAMINATED, AND THUS WILL NOT BE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UNSOLICITED. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT DURING DOUBLE-LUMEN PLACEMENT PROCEDURE ON JUNE-6-2024, THE DISTAL TIP OF THE SCOPE BROKE. NO PATIENT INJURY WAS REPORTED, AND THEY WERE ABLE TO COMPLETE THE PROCEDURE USING A BACK-UP STETHOSCOPE.

Additional Manufacturer Narrative

CORRECTION: UPDATED THE UDI NUMBER IN SECTION B4. PER INVESTIGATION BY THE MANUFACURING SITE: AS NO PRODUCT HAS BEEN RETURNED A FINAL DETERMINATION OF THE ROOT CAUSE IS NOT POSSIBLE. IN SIMILAR CASES WITH THE SAME PRODUCT, EXCESSIVE FORCE DURING APPLICATION LEAD TO DAMAGES AT THE ENDOSCOPE. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).