| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 18GX20CM MAX CORE DISP | BIOPSY GUN | BARD REYNOSA S.A. DE C.V. -9617592 | KNW | MC1820 | REAT1512 | Y | R |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-10-14 | 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 SPRING MECHANISM FAILED AND THE GUN MISFIRED. HOWEVER, THE GUN WAS ALLEGEDLY RE-COCKED AND A SAMPLE WAS ABLE TO BE OBTAINED FROM THE PATIENT.
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 SPRING MECHANISM FAILED AND THE GUN MISFIRED. HOWEVER, THE GUN WAS ALLEGEDLY RE-COCKED AND A SAMPLE WAS ABLE TO BE OBTAINED FROM THE PATIENT.
Patient 1
RECEIVED 1 USED DISPOSABLE MAX-CORE BIOPSY INSTRUMENT WITH THE ORIGINAL UNIT PACKAGING. THE SAMPLE WAS RECEIVED DISASSEMBLED INSIDE A POUCH. THE SAMPLE WAS VISUALLY INSPECTED AND IT SHOWED SIGNS USE. NO VISUAL DEFECTS WERE PRESENT ON THE SAMPLE. A FUNCTIONAL TEST WAS PERFORMED, AND THE SAMPLE WAS COCKED AND FIRED 30 TIMES, 15 TIMES EACH TRIGGER, AND NO DEFECTS WERE FOUND. PER THE MANUFACTURING CONTROLS EVALUATION, ALL MAXCORE DEVICES WERE 100% FUNCTIONALLY DRY FIRED TESTED AT MANUFACTURING AND A SAMPLE WAS TAKEN FROM THE LOT AND FUNCTIONALLY TESTED AGAIN AT QUALITY CONTROL PRIOR TO FINAL RELEASE. THE REPORTED ISSUE WAS UNCONFIRMED AS THE FAILURE COULD NOT BE REPRODUCED. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. 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." (B)(4) 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 SPRING MECHANISM FAILED AND THE GUN MISFIRED. HOWEVER, THE GUN WAS ALLEGEDLY RE-COCKED AND A SAMPLE WAS ABLE TO BE OBTAINED FROM THE PATIENT.