LAPRO-CLIP

Description of Event or Problem

ACCORDING TO THE REPORTER, PRIOR TO USE, EVEN THOUGH THE GRIP WAS SQUEEZED, THE JAWS PART, WHICH FOR CLAMPING THE TIP AND THE CLIP, WERE IN THE STATE THAT COULD NOT BE OPENED AND CLOSED. THERE WAS NO PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5, D4(LOT#), G3 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.

Description of Event or Problem

ACCORDING TO THE REPORTER, PRIOR TO USE, EVEN THOUGH THE GRIP WAS SQUEEZED, THE JAWS PART, WHICH FOR CLAMPING THE TIP AND THE CLIP, WERE IN THE STATE THAT COULD NOT BE OPENED AND CLOSED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE AND A PHOTO WERE AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED THE CLIP REMOVER NOTED THE HOOK WAS IN THE CLOSED POSITION. THE INTERNAL SHAFT WAS INSPECTED AND WAS FOUND MATCH THE DEVICE HOUSING. FUNCTIONALLY, THE HANDLE WAS CYCLED AND THE HOOK REMAINED CLOSED, BUT WHEN THE HANDLE WAS RELEASED THE HOOK DID NOT OPEN. IT WAS REPORTED THAT THE JAWS OF THE RELOAD DID NOT OPEN AT ALL, NOT INVOLVING TISSUE AND THE JAWS OF THE RELOAD DID NOT CLOSE AT ALL. THE REPORTED ISSUES WERE CONFIRMED. THE MOST LIKELY CAUSE WAS TRACED TO AN IDENTIFIED END OF LIFE PROBLEM. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. 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.