SURGINEEDLE

Description of Event or Problem

ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC ROBOTIC CHOLECYSTECTOMY, DURING ABDOMINAL INSUFFLATION AT THE INITIAL ENTRY, THE INSUFFLATION NEEDLE WAS NOT AS SENSITIVE. THE DEVICE DID NOT CLICK WITH EACH LAYER OF FASCIA AND WAS DULL, REQUIRING MORE FORCEFUL PRESSURE WHEN INSERTING INTO THE ABDOMEN TO RESOLVE THE ISSUE TO CONTINUE THE CASE. THERE WAS NO PATIENT INJURY.

Additional Manufacturer Narrative

MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.