ALEXIS O WOUND PROTECTOR-RETRACTOR

Additional Manufacturer Narrative

THE EVENT UNIT WAS RETURNED TO APPLIED MEDICAL FOR EVALUATION. VISUAL INSPECTION OF THE EVENT UNIT CONFIRMED THE COMPLAINANT¿S EXPERIENCE OF SHEATH TEAR. BASED ON THE CONDITION OF THE RETURNED UNIT AND THE DESCRIPTION OF THE EVENT, IT IS LIKELY THAT A SHARP OBJECT OR INSTRUMENT CAME INTO CONTACT WITH THE SHEATH, RESULTING IN A HOLE OR TEAR THAT FURTHER PROPAGATED DUE TO THE STRESS EXPERIENCED BY THE SHEATH. APPLIED MEDICAL HAS PERFORMED A HISTORICAL TREND ANALYSIS AND REVIEW OF PRODUCTION RECORDS AND NO RELEVANT DOCUMENTATION WAS IDENTIFIED.

Description of Event or Problem

PROCEDURE PERFORMED: TLH. EVENT DESCRIPTION: [HOSPITAL] THIS IS A COMPLAINT FROM THE HOSPITAL; THIS HOSPITAL OFTEN USES C8401 IN TLH. DURING SURGERY, THE SHEATH NEAR THE OUTER RING WAS TORN HORIZONTALLY. SINCE THE SHEATH WAS TORN IN A SEMICIRCULAR SHAPE FROM THE SHEATH CONNECTED PART TO THE OTHER SIDE, THE PHYSICIAN STOPPED TO USE IT. REGARDING THE USAGE, NO UNUSUAL HANDLING WAS PERFORMED, AND ANY SHARP INSTRUMENT COMING INTO STRONG SEEMS NOT TO HAVE CONTACTED WITH THE DEVICE. NO PATIENT INJURY OR ILLNESS ASSOCIATED WITH THIS EVENT. REPLACED TO A NEW HOSPITAL INVENTORY C8401 AND PROCEDURE WAS COMPLETED. THE INVESTIGATION REPORT HAS BEEN REQUESTED BY THE HOSPITAL. THIS EVENT UNIT WILL BE RETURNED. INTERVENTION: AFTER CONFIRMING NO PARTS DROPPED IN TO THE ABDOMINAL CAVITY, REPLACED TO A HOSPITAL INVENTORY NEW C8401 AND THE PROCEDURE WAS COMPLETED. PATIENT STATUS: NO PATIENT INJURY INDICATED.

Additional Manufacturer Narrative

THE EVENT UNIT IS ANTICIPATED TO RETURN TO APPLIED MEDICAL. A FOLLOW-UP REPORT WILL BE PROVIDED UPON THE COMPLETION OF THE INVESTIGATION.

Description of Event or Problem

PROCEDURE PERFORMED: TLH EVENT DESCRIPTION: [HOSPITAL] THIS IS A COMPLAINT FROM THE HOSPITAL; THIS HOSPITAL OFTEN USES C8401 IN TLH. DURING SURGERY, THE SHEATH NEAR THE OUTER RING WAS TORN HORIZONTALLY. SINCE THE SHEATH WAS TORN IN A SEMICIRCULAR SHAPE FROM THE SHEATH CONNECTED PART TO THE OTHER SIDE, THE PHYSICIAN STOPPED TO USE IT. REGARDING THE USAGE, NO UNUSUAL HANDLING WAS PERFORMED, AND ANY SHARP INSTRUMENT COMING INTO STRONG SEEMS NOT TO HAVE CONTACTED WITH THE DEVICE NO PATIENT INJURY OR ILLNESS ASSOCIATED WITH THIS EVENT. REPLACED TO A NEW HOSPITAL INVENTORY C8401 AND PROCEDURE WAS COMPLETED. THE INVESTIGATION REPORT HAS BEEN REQUESTED BY THE HOSPITAL. THIS EVENT UNIT WILL BE RETURNED. INTERVENTION: AFTER CONFIRMING NO PARTS DROPPED IN TO THE ABDOMINAL CAVITY, REPLACED TO A HOSPITAL INVENTORY NEW C8401 AND THE PROCEDURE WAS COMPLETED. PATIENT STATUS: NO PATIENT INJURY INDICATED