DISPOSABLE TWO-PART TROCAR NEEDLE
Received Dec 19, 2018 · Event occurred Dec 4, 2018
Report 1820334-2018-03684 · MDR key 8179031
Device
Product problems
- Material Separation
- Material Separation
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION THE DEVICE WAS NOT RETURNED FOR AN EVALUATION AND NO PHOTOGRAPHS WERE PROVIDED. THE LOT NUMBER IS UNKNOWN SO A SEARCH FOR NON CONFORMANCES COULD NOT BE CARRIED OUT. THE LOT NUMBER IS UNKNOWN SO A SEARCH FOR ADDITIONAL COMPLAINTS COULD NOT BE CARRIED OUT. A REVIEW OF QUALITY CONTROL DATA, MANUFACTURING INSTRUCTIONS, REVIEW OF DRAWING, AND REVIEW OF SPECIFICATIONS WAS CONDUCTED. NO COMPLAINT PRODUCT AND PHOTO HAVE BEEN RETURNED FOR ASSESSMENT AND PHYSICAL EVALUATION. WITH THE AVAILABLE INFORMATION THE CONCLUSION OF THIS COMPLAINT IS THAT A CAUSE COULD NOT BE ESTABLISHED. THERE IS NO INDICATION THAT A DESIGN PROCESS OR RELATED FAILURE MODE CONTRIBUTED TO THIS EVENT. CURRENT CONTROLS FOR MANUFACTURING ARE IN PLACE TO ASSURE FUNCTIONALITY AND DEVICE INTEGRITY PRIOR TO SHIPPING. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
Description of Event or Problem
NO NEW EVENT INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED ON (B)(6)2018.
Additional Manufacturer Narrative
COMMON NAME: TROCAR, GASTRO-UROLOGY. PRO-CODE: FBQ. PMA/510K #: EXEMPT. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
Description of Event or Problem
IT IS REPORTED THAT DURING UNSPECIFIED PROCEDURE(S) USING DISPOSABLE TWO-PART TROCAR NEEDLES, THE INNER STYLET DRAGS AND MAKES AN AUDIBLE GRINDING SOUND AS ITS PASSING THROUGH THE DEVICE. ON AN UNKNOWN NUMBER OF OCCASIONS, IT IS REPORTED THAT THE "DEVICE IS SHEARING COATING OFF WIRES AS IT'S PASSING THROUGH". IT IS UNKNOWN IF THERE HAVE BEEN ANY PATIENT ADVERSE EFFECTS AS A RESULT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.