SITUATE

Additional Manufacturer Narrative

THIS REPORT 1717344-2021-00640 WAS SENT IN ERROR AS A DUPLICATE FOR MFR REPORT NUMBER: 1717344-2021-00657, ANY ADDITIONAL INFORMATION RECEIVED IN THE FUTURE WILL BE CAPTURED AND SUBMITTED UNDER THE REPORT NUMBER 1717344-2021-00657. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Additional Manufacturer Narrative

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SPONGE COUNT PERFORMED AT END OF CASE; ALL SPONGES ACCOUNTED FOR BODY SCAN WITH MAT INDICATED A DETECTION. COUNTS WERE RECONFIRMED TWICE. ALL TABLES AND MAYO STAND WERE MOVED FURTHER AWAY FROM THE SURGICAL FIELD. BODY SCAN WITH MAT CONTINUED TO INDICATE DETECTION. SCAN OF PATIENT WITH WAND COULD NOT DETECT ANY SPONGE. AFTER PATIENT MOVED OFF TABLE AND OUT OF ROOM MULTIPLE MAT SCANS PERFORMED WITH NOTHING ON THE TABLE; ALL GAVE DETECTION. MAT MOVED TO MULTIPLE DIFFERENT ROOMS AND USED WITH MULTIPLE CONSOLES AND CABLES; MAT ALWAYS GIVES DETECTION. TRUE DETECTION WITH MAT RULED OUT DUE TO CLEAR SCANS WITH WAND AND MULTIPLE CORRECT SPONGE COUNTS.