QUICK-CORE COAXIAL BIOPSY NEEDLE SET
Report
- Report Number
- 1820334-2020-00789
- Event Type
- Malfunction
- Date Received
- April 9, 2020
- Date of Event
- April 2, 2020
- Report Date
- September 3, 2020
- Manufacturer
- COOK INC
- Product Code
- KNW
- UDI-DI
- 00827002087903
- PMA / PMN Number
- K973565
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION. IT WAS REPORTED THAT A QUICK-CORE COAXIAL BIOPSY NEEDLE SET HAD DIFFICULTY REMOVING THE STYLET FROM THE NEEDLE DURING A LUNG BIOPSY. THIS INCIDENT WAS REPORTED BY REGIONAL IMAGING TASMANIA, IN AUSTRALIA. THE PATIENT REPORTEDLY EXPERIENCED NO ADVERSE EFFECTS AS A RESULT OF THIS INCIDENT. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL, AND SPECIFICATIONS OF THE DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THE RISKS ASSOCIATED WITH THESE DEVICES ARE ACCEPTABLE WHEN WEIGHED AGAINST THE BENEFITS. ALTHOUGH INSPECTION STEPS ARE IN PLACE RELATED TO THIS FAILURE MODE, A PROJECT WAS OPENED TO FURTHER INVESTIGATE/ADDRESS THIS ISSUE. THE DEVICE HISTORY RECORD (DHR) REVIEW ON THE COMPLAINT LOT AND RELATED SUBASSEMBLY LOTS RECORDED NO NON-CONFORMANCES. A DATA BASE SEARCH REVEALED NO ADDITIONAL COMPLAINTS FOR THE COMPLAINT LOT FROM THE FIELD. AS THERE ARE NO RELATED NON-CONFORMANCES, ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED, THERE IS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, AND NO OTHER LOT RELATED COMPLAINTS THAT HAVE BEEN RECEIVED FROM THE FIELD, IT WAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. THE PRODUCT IFU, ¿QUICK-CORE BIOPSY NEEDLES AND SETS,¿ PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: INSTRUCTIONS FOR USE ¿IF USING THE COAXIAL NEEDLE, INSERT THE COAXIAL NEEDLE TO THE BORDER OF THE LESION.¿ BASED ON THE INFORMATION PROVIDED, NO RETURNED PRODUCT, AND THE RESULTS OF THE INVESTIGATION, A DEFINITIVE CAUSE COULD NOT BE ESTABLISHED. A PROJECT WAS OPENED TO FURTHER INVESTIGATE/ADDRESS THIS ISSUE. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
ADDITIONAL INFORMATION: THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. 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.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN OR UNAVAILABLE. ADDITIONAL INFORMATION: SECTION C, D10, H3, H6 - METHOD CODE. D10 ¿ PRODUCT RECEIVED ON: 19AUG2020. INVESTIGATION ¿ EVALUATION: THE DEVICE WAS RETURNED ON 19AUG2020, THEREFORE THE INVESTIGATION WAS REOPENED TO INCLUDE THE ADDITIONAL INFORMATION. VISUAL INSPECTION AND DIMENSIONAL VERIFICATION OF THE RETURNED DEVICE WERE CONDUCTED. THE COMPLAINANT RETURNED A COAXIAL NEEDLE ASSEMBLY FROM A QUICK-CORE COAXIAL BIOPSY NEEDLE SET TO COOK FOR INVESTIGATION. THE PHYSICAL/VISUAL EXAMINATION SHOWED: ONE COAXIAL NEEDLE ASSEMBLY WITH NO VISIBLE DAMAGE. THE TROCAR AND CANNULA WERE ABLE TO BE SEPARATED BY HAND. THE TROCAR OUTSIDE DIAMETER (OD) AND THE CANNULA INSIDE DIAMETER BOTH MEASURED WITHIN SPECIFICATION. AS PREVIOUSLY REPORTED: BASED ON THE INFORMATION PROVIDED, EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. A PROJECT IS CURRENTLY OPEN TO FURTHER INVESTIGATE/ADDRESS THIS ISSUE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
OCCUPATION: UNKNOWN. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
IT WAS REPORTED A QUICK-CORE COAXIAL BIOPSY NEEDLE SET WAS USED ON A MALE PATIENT DURING A LUNG BIOPSY. THE OPERATOR REPORTED BEING UNABLE TO REMOVE THE STYLET FROM THE NEEDLE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 406453 | QUICK-CORE COAXIAL BIOPSY NEEDLE SET | KNW INSTRUMENT, BIOPSY | KNW | COOK INC | N/A | 9370798 | 00827002087903 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |