QUICK-CORE COAXIAL BIOPSY NEEDLE SET
Report
- Report Number
- 1820334-2018-00993
- Event Type
- Malfunction
- Date Received
- April 13, 2018
- Date of Event
- March 23, 2018
- Report Date
- July 9, 2018
- Manufacturer
- COOK INC
- Product Code
- KNW
- UDI-DI
- 00827002087903
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- NURSE
Narratives
A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, REVIEW OF DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL, AND INSPECTION/ FUNCTIONAL TEST/DIMENSIONAL VERIFICATION OF THE UNUSED PRODUCT WAS CONDUCTED DURING THE INVESTIGATION. THE DEVICE WAS RETURNED IN AN OPENED BUT UNUSED CONDITION. THE DTN-16-11.0-M3-QCS-U-IS (COAXIAL SUPPORT NEEDLE ASSEMBLY) WAS RETURNED WITH THE TROCAR STYLET INSERTED THROUGH THE METAL CANNULA. ATTEMPTS TO REMOVE THE TROCAR STYLET FROM THE CANNULA WERE MET WITH RESISTANCE. THE TROCAR STYLET WAS EVENTUALLY REMOVED WITH DIFFICULTY. FURTHER INSERTION AND REMOVAL BETWEEN THE TROCAR STYLET AND CANNULA WAS NOT MET WITH ANY RESISTANCE. THE LUER LOCKING OBTURATOR HUB CAN BE TIGHTENED DOWN AND IT APPEARS THAT IT WAS TWISTED ON SO TIGHTLY AS TO MAKE IT DIFFICULT TO UNTWIST AND SEPARATE THE TROCAR STYLET FROM THE CANNULA. A DOCUMENT-BASED INVESTIGATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE FINISHED PRODUCT WAS NOT MADE TO SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORD OF THE FINISHED PRODUCT SHOWS NO NONCONFORMING EVENTS. A COMPLAINT HISTORY SEARCH REVEALED THAT THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. IFU STATES: ¿UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED". BASED ON THE INFORMATION PROVIDED, EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, IT WAS DETERMINED THE POSSIBLE ROOT CAUSE WAS MANUFACTURING RELATED (OPERATOR/PROCESS RELATED). THE APPROPRIATE PERSONNEL WERE NOTIFIED AND WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER QUALITY ENGINEERING RISK ASSESSMENT, THERE IS NO FURTHER ACTIONS REQUIRED AT THIS TIME.
A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, REVIEW OF DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL, AND INSPECTION/ FUNCTIONAL TEST/DIMENSIONAL VERIFICATION OF THE UNUSED PRODUCT WAS CONDUCTED DURING THE INVESTIGATION. THE DEVICE WAS RETURNED IN AN OPENED BUT UNUSED CONDITION. THE DTN-16-11.0-M3-QCS-U-IS (COAXIAL SUPPORT NEEDLE ASSEMBLY) WAS RETURNED WITH THE TROCAR STYLET INSERTED THROUGH THE METAL CANNULA. ATTEMPTS TO REMOVE THE TROCAR STYLET FROM THE CANNULA WERE MET WITH RESISTANCE. THE TROCAR STYLET WAS EVENTUALLY REMOVED WITH DIFFICULTY. FURTHER INSERTION AND REMOVAL BETWEEN THE TROCAR STYLET AND CANNULA WAS NOT MET WITH ANY RESISTANCE. THE LUER LOCKING OBTURATOR HUB CAN BE TIGHTENED DOWN AND IT APPEARS THAT IT WAS TWISTED ON SO TIGHTLY AS TO MAKE IT DIFFICULT TO UNTWIST AND SEPARATE THE TROCAR STYLET FROM THE CANNULA. A DOCUMENT-BASED INVESTIGATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE FINISHED PRODUCT WAS NOT MADE TO SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORD OF THE FINISHED PRODUCT SHOWS NO NONCONFORMING EVENTS. A COMPLAINT HISTORY SEARCH REVEALED THAT THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. IFU STATES: ¿UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED". BASED ON THE INFORMATION PROVIDED, EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, IT WAS DETERMINED THE POSSIBLE ROOT CAUSE WAS MANUFACTURING RELATED (OPERATOR/PROCESS RELATED). THE APPROPRIATE PERSONNEL WERE NOTIFIED AND WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER QUALITY ENGINEERING RISK ASSESSMENT, THERE IS NO FURTHER ACTIONS REQUIRED AT THIS TIME.
NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.
NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.
(B)(4). 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.
IT WAS REPORTED THE RADIOLOGIST CHECKED THE REMOVAL OF STYLET FROM INTRODUCER NEEDLE IN THE QUICK-CORE COAXIAL BIOPSY NEEDLE SET PRIOR TO COMMENCING PROCEDURE IN PREPARATION FOR A CORE BIOPSY ON THE SOFT TISSUE AROUND THE LEVEL OF THE DISCITIS. THE RADIOLOGIST WAS UNABLE TO REMOVE THE STYLET FROM INTRODUCER NEEDLE AND CONTINUED ON WITH BIOPSY WITHOUT THE USE OF THE INTRODUCER NEEDLE. THE RADIOLOGIST FURTHER CLARIFIED HE DID A ONE SHOT BIOPSY BY MAKING AN INCISION AND GUIDING THE BIOPSY NEEDLE INTO PLACE BY ITSELF (JUST LIKE THEY DO WITH OUR BREAST BIOPSIES USING A QUICK CORE BIOPSY NEEDLE THAT DOESN'T COME WITH AN INTRODUCER) UNDER COMPUTER TOMOGRAPHY (CT). ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 271692 | QUICK-CORE COAXIAL BIOPSY NEEDLE SET | KNW INSTRUMENT, BIOPSY | KNW | COOK INC | 00827002087903 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR |