ALEXIS O WOUND PROTECTOR-RETRACTOR

Additional Manufacturer Narrative

THE EVENT UNIT WAS NOT RETURNED TO APPLIED MEDICAL FOR EVALUATION. HOWEVER, PHOTOS OF THE EVENT UNIT WERE PROVIDED, CONFIRMING THE COMPLAINANT¿S EXPERIENCE OF SHEATH TEAR. BASED ON THE DESCRIPTION OF THE EVENT AND THE PHOTOS PROVIDED, IT IS LIKELY THAT A SHARP OBJECT OR INSTRUMENT CAME INTO CONTACT WITH THE SHEATH, RESULTING IN HOLES OR TEARS THAT FURTHER PROPAGATED DUE TO THE STRESS EXPERIENCED BY THE SHEATH. THE INSTRUCTIONS FOR USE (IFU) STATES, "AVOID SHARP INSTRUMENTS CONTACTING THE DEVICE, AS IT MAY DAMAGE THE DEVICE OR CAUSE PATIENT INJURY." APPLIED MEDICAL HAS PERFORMED A HISTORICAL TREND ANALYSIS AND REVIEW OF PRODUCTION RECORDS AND NO TRENDS WERE IDENTIFIED.

Description of Event or Problem

PROCEDURE PERFORMED: (B)(6). EVENT DATE: UNKNOWN. EVENT DESCRIPTION: I HAVE BEEN ALERTED BY MY CLINICAL COLLEAGUE (NAME REDACTED) THAT WHILST IN THE OPERATING THEATRE 2 OF YOUR PRODUCT C8401 HAVE BROKEN WHILST IN USE. (NAME REDACTED) WILL BE ABLE TO HAVE THE APPROPRIATE TEAM MEMBER EXPLAIN THE BEHAVIOR OF THIS ITEM PRIOR TO USE AND WHILST IN USE IN A HOPE YOUR TEAM CAN WORK OR THE CAUSATION OF THIS OCCURRENCE. THE LOT NUMBERS OF BOTH USED ALEXIS RING (SMALL) IS AS FOLLOWS (1550713). ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 27JAN26: IMAGES IN THE ATTACHMENTS. I HAVE REQUESTED THE BELOW INFORMATION FROM THE CUSTOMER AND HAVE ATTACHED 2 PICTURES THEY SENT TO ME. AS SOON AS I CAN OBTAIN ANY ADDITIONAL INFORMATION I WILL INFORM YOU. INTERVENTION: (B)(6). PATIENT STATUS: NO PATIENT INJURY REPORTED.

Additional Manufacturer Narrative

THE EVENT UNIT IS NOT BEING RETURNED TO APPLIED MEDICAL FOR EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem

PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: I HAVE BEEN ALERTED BY MY CLINICAL COLLEAGUE (NAME REDACTED) THAT WHILST IN THE OPERATING THEATRE 2 OF YOUR PRODUCT C8401 HAVE BROKEN WHILST IN USE. (NAME REDACTED) WILL BE ABLE TO HAVE THE APPROPRIATE TEAM MEMBER EXPLAIN THE BEHAVIOR OF THIS ITEM PRIOR TO USE AND WHILST IN USE IN A HOPE YOUR TEAM CAN WORK OR THE CAUSATION OF THIS OCCURRENCE. THE LOT NUMBERS OF BOTH USED ALEXIS RING (SMALL) IS AS FOLLOWS (B)(6). ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 27JAN2026: IMAGES IN THE ATTACHMENTS. I HAVE REQUESTED THE BELOW INFORMATION FROM THE CUSTOMER AND HAVE ATTACHED 2 PICTURES THEY SENT TO ME. AS SOON AS I CAN OBTAIN ANY ADDITIONAL INFORMATION I WILL INFORM YOU. INTERVENTION: NI. PATIENT STATUS: NO PATIENT INJURY REPORTED.