ENDO DISSECT

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 LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE HAD CURVED JAWS THAT CAUSED UNWANTED TISSUE CAUTERIZATIONS. TWO DIFFERENT DEVICES WERE OPENED IN THE SAME CASE, BUT BOTH THE DISSECTOR COULD NOT BE FULLY CLOSED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE DURATION OF THE ANESTHESIA WAS EXTENDED BECAUSE OF THE DEVICE REPLACEMENT, THUS EXTENDING THE SURGICAL TIME FOR 30 MINUTES OR MORE. THERE WAS A SMALL AMOUNT OF TISSUE DAMAGE DUE TO THE CAUTERIZATION. PATIENT IS ALIVE.

Additional Manufacturer Narrative

EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. THE EVALUATION FOUND NO POTENTIALLY CONTRIBUTING FACTORS, AND THE SAMPLE MET ALL RELATED SPECIFICATIONS. IT WAS REPORTED THAT THE JAWS WERE DIFFICULT TO OPEN OR CLOSE. THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE IDENTIFIED BECAUSE NO RELATED PROBLEM WAS DETECTED WITH THE DEVICE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. A SECONDARY REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO POTENTIALLY CONTRIBUTING FACTORS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE HAD CURVED JAWS THAT CAUSED UNWANTED TISSUE CAUTERIZATIONS. TWO DIFFERENT DEVICES WERE OPENED IN THE SAME CASE, BUT BOTH THE DISSECTOR COULD NOT BE FULLY CLOSED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE DURATION OF THE ANESTHESIA WAS EXTENDED BECAUSE OF THE DEVICE REPLACEMENT, THUS EXTENDING THE SURGICAL TIME FOR 30 MINUTES OR MORE.