ENDO SHEARS WITH UNIPOLAR CAUTERY

Additional Manufacturer Narrative

COMMON DEVICE NAME: ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, REPROCESSED. THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 22-DEC-2022. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY STERILMED, INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, STERILMED, INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. BIOSENSE WEBSTER MANUFACTURER'S REFERENCE NUMBER (B)(4) HAS TWO COMPLAINTS THAT ARE RELATED TO THE SAME INCIDENT. MANUFACTURER'S REF. NO: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH TWO ENDO SHEARS WITH UNIPOLAR CAUTERY FOR STERILITY INTEGRITY COMPROMISED ISSUES. DEVICE WAS POKING OUT OF THE BAG AND NO LONGER STERILE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THE POUCH HAD A HOLE IN IT AND THE TIP OF THE DEVICE WAS POKING OUT OF IT. NO FOREIGN MATERIAL OR SPOT OBSERVED ON THE DEVICE. THE DAMAGE COULD BE RELATED TO SHIPPING OR HANDLING. THE EVENT WAS ASSESSED AS MDR REPORTABLE UNDER BOTH THE ENDO SHEARS WITH UNIPOLAR CAUTERY FOR STERILITY INTEGRITY COMPROMISED ISSUES.

Additional Manufacturer Narrative

IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH TWO ENDO SHEARS WITH UNIPOLAR CAUTERY FOR STERILITY INTEGRITY COMPROMISED ISSUES. DEVICE WAS POKING OUT OF THE BAG AND NO LONGER STERILE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THE POUCH HAD A HOLE IN IT AND THE TIP OF THE DEVICE WAS POKING OUT OF IT. NO FOREIGN MATERIAL OR SPOT OBSERVED ON THE DEVICE. THE DAMAGE COULD BE RELATED TO SHIPPING OR HANDLING. THE DEVICE EVALUATION WAS COMPLETED ON 03-FEB-2023. THE RETURNED DEVICE IS A COVIDIEN AUTOSUTURE ENDOSHEAR AUT176643. THE DEVICE WAS RETURNED STILL SEALED INSIDE ITS ORIGINAL PACKAGING, WHICH THE LABEL NOTED DEVICE ID AS 01254061 FROM LOT 2172905. THE DEVICE IS OBSERVED TO HAVE A CLAY BOARD LAPAROSCOPIC HOLDER SLEEVE OVER THE HANDLE. AS WELL, A TIP PROTECTOR IS POSITIONED OVER THE CUTTING BLADES. THE PACKAGE SURFACE AREA, ON BOTH THE TYVEK AND CLEAR POLY SIDE, APPEAR WHOLE AND INTACT. THE SEAL WAS EXAMINED, AND THERE IS A BREACH IDENTIFIED IN THE SEAL OF THE PROXIMAL SIDE OF THE PACKAGE (OPPOSITE THE CHEVRON OPENING). THE SEAL IS WIDE ENOUGH TO FIT THE DISTAL TIP OF THE DEVICE. THIS BREACH CONFIRMS THE REPORTED ISSUE. THE BREACH OF THE SEAL IS CAUSED BY THE DISTAL TIP OF THE DEVICE PRESSING AND PUSHING THROUGH THE SEAL IS A LIKELY CAUSE OF THE REPORTED ISSUE. HOWEVER, IT IS NOT DETERMINED IF THIS IS CAUSED DURING SHIPPING OF THE DEVICE OR BY HANDLING AND STORAGE ACTIVITIES AFTER THE DEVICE WAS REMOVED FROM ITS SHIPPING CONTAINER. ALL REPROCESSED LAPAROSCOPIC DEVICES AND PACKAGES ARE 100% VISUALLY INSPECTED PRIOR TO BEING DISTRIBUTED TO THE CUSTOMER. THE DHR FOR LOT 2172905 WAS REVIEWED AND THE DEVICE PASSED ALL FINISHED GOODS INSPECTION CRITERIA. AN MRE WAS CONDUCTED AND THERE WERE NO IDENTIFIED INTERNAL ACTIONS. AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO INVESTIGATE THE BREACH IN THE PACKAGE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).