SINGLE-USE FLEXIBLE RHINOLARYNGOSCOPE

Additional Manufacturer Narrative

A COMPREHENSIVE REVIEW OF THE RELEVANT PRODUCTION RECORDS, INSPECTION REPORTS, AND TEST DATA FOR CRITICAL RAW MATERIALS WAS CONDUCTED. NO ABNORMALITIES WERE IDENTIFIED, THEREBY ALLOWING US TO REASONABLY EXCLUDE DEFECTS RELATED TO RAW MATERIALS, COMPONENTS, OR MANUFACTURING PROCESSES. HOWEVER, THE POSSIBILITY OF AN INFREQUENT OR ISOLATED ISSUE RELATED TO INADEQUATE CONNECTIVITY, POTENTIALLY RESULTING IN INSUFFICIENT STRUCTURAL INTEGRITY, CANNOT BE COMPLETELY RULED OUT. ALTHOUGH THE PROCEDURE WAS PERFORMED AT THE BEDSIDE IN ACCORDANCE WITH STANDARD OPERATING PROTOCOLS, THE POTENTIAL FOR IMPROPER HANDLING, SUCH AS EXCESSIVE FORCE OR SUBOPTIMAL ANGULATION DURING OPERATION, CANNOT BE ENTIRELY EXCLUDED AS A CONTRIBUTING FACTOR TO THE BREAKAGE OF THE ENDOSCOPE TIP. THE ASSESSMENT OF THE PRODUCT USER MANUAL (IFU) INDICATES THAT IT HAS BEEN STATED IN THE MANUAL: "THE ENDOSCOPE IS INTENDED FOR USE IN A HOSPITAL ENVIRONMENT. IT IS DESIGNED FOR USE IN ADULTS.". DUE TO THE LACK OF DETAILED INFORMATION, WE WERE UNABLE TO CONFIRM THE DIMENSIONS OF THE CATHETER THAT MIGHT BE USED TOGETHER. IF THE INTERNAL DIAMETER OF THE CATHETER WAS INSUFFICIENT, IT MAY CAUSE THE ENDOSCOPE TO BECOME LODGED WITHIN THE CATHETER, LEADING TO THE TIP'S FRACTURE DURING REMOVAL OR REPOSITIONING. PROPOSED ACTIONS MAY INCLUDE: ENHANCING THE CLARITY AND VISIBILITY OF INSTRUCTIONS RELATED TO COMPATIBLE ACCESSORIES IN THE IFU; STRENGTHENING TRAINING PROGRAMS FOR OUR SALES PERSONNEL TO REINFORCE AWARENESS OF CRITICAL USAGE PRECAUTIONS; AND ENSURING THAT END USERS, INCLUDING HOSPITALS AND CLINICAL STAFF, ARE APPROPRIATELY INFORMED AND TRAINED. ADDITIONALLY, WE WILL CONSIDER EXPLICITLY INDICATING THE MINIMUM REQUIRED INTERNAL DIAMETER FOR COMPATIBLE CATHETERS TO MINIMIZE THE RISK OF SIMILAR INCIDENTS.

Description of Event or Problem

DURING A BEDSIDE PROCEDURE, THE TIP OF A DISPOSABLE FLEXIBLE ENDOSCOPE HAD BROKEN OFF, WHICH CAUSED IT TO BE LODGED INSIDE OF TRACHEOSTOMY TUBE.