QUICK-CORE COAXIAL BIOPSY NEEDLE SET
Report
- Report Number
- 1820334-2020-00211
- Event Type
- Malfunction
- Date Received
- January 27, 2020
- Date of Event
- December 2, 2019
- Report Date
- June 4, 2020
- Manufacturer
- COOK INC
- Product Code
- KNW
- UDI-DI
- 00827002087286
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
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. D10 ¿ PRODUCT RECEIVED ON: 12MAY2020 INVESTIGATION ¿ EVALUATION IT WAS REPORTED THAT A QUICK-CORE COAXIAL BIOPSY NEEDLE SET WAS DIFFICULT TO UNSCREW. THIS FAILURE WAS NOTED AFTER THE DEVICE PUNCTURED THE PATIENT¿S CERVICAL LYMPH NODES FOR AN UNKNOWN PROCEDURE. COOK BECAME AWARE OF THIS EVENT UPON BEING NOTIFIED BY NANSHAN DISTRICT PEOPLE'S HOSPITAL. THE PATIENT REPORTEDLY EXPERIENCED NO ADVERSE EFFECTS AS A RESULT OF THIS INCIDENT. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL, AND SPECIFICATIONS OF THE DEVICE, AS WELL AS A VISUAL INSPECTION, FUNCTIONAL TEST, AND DIMENSIONAL VERIFICATION, WERE CONDUCTED DURING THE INVESTIGATION. ONE QCS SET WAS RETURNED, CONSISTING OF A COAXIAL NEEDLE SUBASSEMBLY (DTN) AND A BIOPSY NEEDLE (QC). NO DAMAGE WAS NOTED ON EITHER DEVICE. THE DTN WAS RETURNED SCREWED TOGETHER, AND WAS EASILY UNSCREWED BY HAND. THE DTN WAS RETIGHTENED BY HAND AND STILL EASILY CAME APART; THE FAILURE COULD NOT BE REPLICATED. THE RETURNED DEVICE SUGGESTS THAT THE DEVICE WAS MANUFACTURED WITHIN SPECIFICATION. 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 OF THE COMPLAINT LOT SHOWED TWO NONCONFORMANCES, ONE RELATED TO THE FAILURE MODE AND ONE UNRELATED. THE RELATED NONCONFORMANCE WAS LATER DISPOSITIONED AS CONFORMING, SO THERE WERE NO RELATED NONCONFORMANCES WHEN THIS LOT WAS SHIPPED. COAXIAL NEEDLE SUBASSEMBLY LOT SHOWED NO NONCONFORMANCES. A DATABASE SEARCH REVEALED NO OTHER COMPLAINTS FROM THE COMPLAINT LOT AT THE TIME OF INVESTIGATION. SINCE THERE WERE NO RELATED NONCONFORMANCES AT THE END OF MANUFACTURING AND NO OTHER COMPLAINTS FROM THIS LOT, THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN THE FIELD. INSTRUCTIONS FOR USE (IFU) DOCUMENT IS PACKAGED WITH THIS DEVICE. RELEVANT SECTIONS INCLUDE: INTENDED USE ¿ QUICK-CORE BIOPSY NEEDLES ARE INTENDED FOR SOFT TISSUE BIOPSY. THE PRODUCT IS INTENDED FOR USE BY PHYSICIANS TRAINED AND EXPERIENCED IN DIAGNOSTIC AND INTERVENTIONAL TECHNIQUES. STANDARD TECHNIQUES FOR SOFT TISSUE BIOPSY SHOULD BE EMPLOYED. HOW SUPPLIED ¿ UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED. IT IS POSSIBLE THAT THE DEVICE WAS SCREWED TOO TIGHTLY DURING QUALITY CONTROL, BUT THIS POTENTIAL CAUSE OF FAILURE CANNOT BE CONFIRMED SINCE THE RETURNED COMPLAINT DEVICE WAS ABLE TO BE UNSCREWED BY HAND WITHOUT DIFFICULTY. ANOTHER UNKNOWN FACTOR MAY BE CONTRIBUTING TO THE DTN BECOMING UNABLE TO BE UNSCREWED. A PROJECT HAS BEEN OPENED TO FURTHER INVESTIGATE/ADDRESS THIS ISSUE. BASED ON THE INFORMATION PROVIDED, INSPECTION OF RETURNED PRODUCT AND THE RESULTS OF THE INVESTIGATION, A DEFINITIVE CAUSE COULD NOT BE ESTABLISHED. 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.
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.
DEVICE AVAILABLE FOR EVALUATION: UNKNOWN. (B)(6). OCCUPATION: UNKNOWN. REPORT SOURCE - OTHER: COMPETENT AUTHORITY, COUNTRY OF ORIGIN: (B)(6). PMA/510(K) #: K973565. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
AS REPORTED, A (B)(6)-YEAR-OLD FEMALE REQUIRED A QUICK-CORE COAXIAL BIOPSY NEEDLE SET FOR A PROCEDURE INVOLVING CERVICAL LYMPH NODES. THE OPERATOR REPORTS THAT AFTER THE NEEDLE PUNCTURED AND REACHED THE CERVICAL LYMPH NODES, "THE COAXIAL NEEDLE ASSEMBLY WAS DIFFICULT TO UNSCREW." THE DEVICE WAS REMOVED FROM THE PATIENT AND A SIMILAR DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 |
|---|---|---|---|---|---|---|---|
| 96625 | QUICK-CORE COAXIAL BIOPSY NEEDLE SET | KNW INSTRUMENT, BIOPSY | KNW | COOK INC | N/A | 9796965 | 00827002087286 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR |