| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | MAXCORE DISPOSABLE BIOPSY GUN | BIOPSY GUN | BARD REYNOSA S.A. DE C.V. -9617592 | KNW | MC1820 | REZJ1054 | Y | R |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-01-21 | 0 |
Patient 1
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.
Patient 1
IT WAS REPORTED THAT THE PRODUCT WORKED PROPERLY IN THE BEGINNING BUT TOWARD THE END OF THE SERIES OF BIOPSIES, THE GUN BEGAN TO MISFIRE.
Patient 1
RECEIVED 1 USED MAX-CORE BIOPSY INSTRUMENT WITH THE ORIGINAL UNIT PACKAGING. VISUAL INSPECTION NOTED NO OBVIOUS DEFECTS. THE NEEDLE SHEATH WAS NOT RETURNED. A FUNCTIONAL TEST WAS PERFORMED. THE COMPLAINT SAMPLE WAS TESTED 30 TIMES, 15 TIMES WITH EACH TRIGGER. ALL TIMES THE DEVICE COCKED AND FIRE PROPERLY (30/0), THE SAMPLE WAS PREPARED AND FIRED WITHOUT ANY PROBLEMS. THE SAMPLE FUNCTIONED CORRECTLY DURING THE FUNCTIONAL TESTING. ALL MAXCORE DEVICES ARE 100% FUNCTIONALLY DRY FIRE TESTED AT THE MANUFACTURING FACILITY BEFORE DISTRIBUTION. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE COMPLAINT WAS UNCONFIRMED AS THE PROBLEM COULD NOT BE REPRODUCED. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING: "ENERGIZE (COCK) INSTRUMENT BY PULLING BACK ON THE TOP SLIDE TO WITHDRAW THE CANNULA AND LOCK IN PLACE. THEN PULL BACK ON THE BOTTOM SLIDE TO WITHDRAW THE STYLET AND LOCK IN PLACE. REMOVE PROTECTIVE NEEDLE SHEATH AND YELLOW GUARD. INSTRUMENT IS READY TO FIRE WHEN BOTH SLIDES ARE LOCKED BACK. WHILE MAINTAINING INSTRUMENT'S POSITION AND THE NEEDLE ORIENTATION, DEPRESS THE REAR ACTUATOR BUTTON, OR PUSH THE SIDE ACTUATOR FORWARD (DIRECTION OF ARROW), TO CAUSE BOTH STYLET AND CANNULA TO AUTOMATICALLY ADVANCE." THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.