ONCONTROL COAXIAL BIOPSY TRAY 11/13 GA
Report
- Report Number
- 1036844-2019-01015
- Event Type
- Malfunction
- Date Received
- November 13, 2019
- Date of Event
- October 3, 2019
- Report Date
- October 22, 2019
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- FCG
- PMA / PMN Number
- K113872
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4). THE DHR FILE IS NOT AVAILABLE FOR REVIEW IN THE US. THE FOLLOWING COMPONENTS FROM THE BONE LESION BIOPSY TRAY, 9464-VC-006, ONCONTROL COAXIAL BIOPSY TRAY 11/13 GA, WAS RECEIVED. ONE (1) BONE ACCESS NEEDLE SET, ONE (1) BONE ACCESS EJECTOR ROD, ONE (1) EJECTOR ASSIST, ONE (1) BONE LESION BIOPSY NEEDLE, AND ONE (1) BONE LESION BIOPSY EJECTOR ROD. UPON RECEIPT ALL COMPONENTS WERE VISUALLY EXAMINED FOR ANY SIGN OF ABUSE/MISUSE/DAMAGE. VISUAL INSPECTION CONFIRMED ONE (1) BONE LESION BIOPSY NEEDLE THAT HAD BEEN "TWISTED" OFF LEAVING A PORTION OF THE NEEDLE IN THE PATIENT (PER THE DETAILED DEFECT DESCRIPTION). ALSO , DAMAGE WAS THE CANNULA COMPONENT OF THE BONE ACCESS NEEDLE SET. THE CANNULA IS SEVERELY BENT. THE COMPLAINT FOCUSES ON THE "BIOPSY DEVICE" OF WHICH A PIECE BROKE OFF INSIDE THE PATIENT'S BONE. VISUAL INSPECTION CONFIRMED THE BONE LESION BIOPSY NEEDLE WAS TWISTED OR TURNED SO HARD IT COMPLETELY BROKE OFF THE CONNECTOR END. VISUAL INSPECTION ALSO CONFIRMS THE CANNULA COMPONENT OF THE BONE ACCESS NEEDLE SET WAS HEAVY DAMAGED (BENT). HOWEVER, CONFIRMATION OF A BROKEN PIECE OF THE CANNULA IN THE PATIENT CANNOT BE MADE. THE COMPLAINT HAS BEEN CONFIRMED FROM THE PERSPECTIVE OF "DAMAGED" COMPONENTS. HOW THE BIOPSY NEEDLE BROKE OFF IN THE PATIENT IS NOT UNDERSTOOD WITH THE CURRENT REPORTED DESCRIPTION. THE COMPLAINT HAS BEEN CONFIRMED MINUS A DEFINITIVE ROOT CAUSE ASSIGNMENT. A SECTION OF THE IFU WILL BE REFERENCED AS PART OF THIS INVESTIGATION REPORT. THE IFU STATES , "4. INSERT BONE ACCESS NEEDLE SET INTO INTENDED LOCATION USING THE CORRECT ANGLE. ATTACH DRIVER TO NEEDLE SET. WHEN CORRECTLY INSERTED, THE NEEDLE SET WILL SECURE INTO CONNECTOR WITH A "CLICK". 3. TIGHTEN STYLET AND HUB OF THE BONE ACCESS NEEDLE SET. 5. FIND LOCATION ON BONE, NOTE DEPTH MARKING AND SQUEEZE TRIGGER TO ACTIVATE DRIVER. DO NOT APPLYEXCESSIVE FORCE TO DRIVER/NEEDLE SET. SQUEEZE TRIGGER UNTIL BONE ACCESS NEEDLE SET HAS REACHED THE DESIRED LOCATION TO BE BIOPSIED. 6. DETACH POWER DRIVER FROM THE BONE ACCESS NEEDLE SET. 11. DETACH POWER DRIVER FROM THE BONE LESION BIOPSY NEEDLE SET. 7. REMOVE STYLET. IF NEEDED, USE THE MANUAL HANDLE FOR MINOR ADJUSTMENTS OF THE BONE ACCESS CANNULA. BONE LESION BIOPSY NEEDLE SET SHOULD ALWAYS BE USED INSIDE THE ACCESS NEEDLE. DO NOT USE THE BONE LESION BIOPSY NEEDLE SET INDEPENDENTLY OF THE ACCESS NEEDLE. 8. PLACE THE BONE LESION BIOPSY NEEDLE INSIDE THE BONE ACCESS CANNULA. 9. FOR BONE LESION, ATTACH POWER DRIVER TO BONE LESION BIOPSY NEEDLE HUB, USE DEPTH MARKERS AS GUIDE. 10. IN ONE CONTINUOUS MOTION, SQUEEZE TRIGGER, AND ADVANCE BONE LESION BIOPSY NEEDLE (UP TO 1.5 CM AS ALLOWED BY THE BONE ACCESS CANNULA); WITH THE TRIGGER STILL ENGAGED, PULL UP ON POWER DRIVER UNTIL BONE LESION BIOPSY NEEDLE IS COMPLETELY REMOVED FROM PATIENT. THE CERTIFICATE OF COMPLIANCE CERTIFIES THAT THE REFERENCED PRODUCT WAS MANUFACTURED, INCLUDING RECONCILIATION OF PRINTED LABEL QUANTITIES, USING AGREED UPON SPECIFICATIONS AND IN ACCORDANCE WITH FDA AND ISO QUALITY SYSTEM REQUIREMENTS. STERILE-LABELED PRODUCTS WERE PROCESSED FOR STERILITY IN A VALIDATED CYCLE USING 199 ETHYLENE OXIDE GAS." THE COMPLAINT HAS BEEN CONFIRMED STRICTLY FROM A VISUAL INSPECTION PERSPECTIVE. CLOSE UP PHOTOS REVEAL THE TWISTED METAL END OF THE LESION BIOPSY NEEDLE. OBVIOUSLY, THE BIOPSY NEEDLE WAS IN A VERY HARD MATTER, BUT WHETHER OR NOT THE PROPER NEEDLE RETRIEVAL TECHNIQUE WAS PRACTICED, OR IF THE CORRECT MANUAL NEEDLE REMOVAL TECHNIQUE TO REMOVE A NEEDLE WAS EXECUTED CANNOT BE DETERMINED. A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED.
(B)(4). THE FOLLOWING COMPONENTS FROM THE BONE LESION BIOPSY TRAY, 9464-VC-006, ONCONTROL COAXIAL BIOPSY TRAY 11/13 GA, WAS RECEIVED. ONE (1) BONE ACCESS NEEDLE SET, ONE (1) BONE ACCESS EJECTOR ROD, ONE (1) EJECTOR ASSIST, ONE (1) BONE LESION BIOPSY NEEDLE, AND ONE (1) BONE LESION BIOPSY EJECTOR ROD. UPON RECEIPT ALL COMPONENTS WERE VISUALLY EXAMINED FOR ANY SIGN OF ABUSE/MISUSE/DAMAGE. VISUAL INSPECTION CONFIRMED ONE (1) BONE LESION BIOPSY NEEDLE THAT HAD BEEN "TWISTED" OFF LEAVING A PORTION OF THE NEEDLE IN THE PATIENT (PER THE DETAILED DEFECT DESCRIPTION). ALSO, DAMAGED WAS THE CANNULA COMPONENT OF THE BONE ACCESS NEEDLE SET. THE CANNULA IS SEVERELY BENT. THE COMPLAINT FOCUSES ON THE "BIOPSY DEVICE" OF WHICH A PIECE BROKE OFF INSIDE THE PATIENT'S BONE. VISUAL INSPECTION CONFIRMED THE BONE LESION BIOPSY NEEDLE WAS TWISTED OR TURNED SO HARD IT COMPLETELY BROKE OFF THE CONNECTOR END. VISUAL INSPECTION ALSO CONFIRMS THE CANNULA COMPONENT OF THE BONE ACCESS NEEDLE SET WAS HEAVILY DAMAGED (BENT). HOWEVER, CONFIRMATION OF A BROKEN PIECE OF THE CANNULA IN THE PATIENT CANNOT BE MADE. THE COMPLAINT HAS BEEN CONFIRMED FROM THE PERSPECTIVE OF "DAMAGED" COMPONENTS. HOW THE BIOPSY NEEDLE BROKE OFF IN THE PATIENT IS NOT UNDERSTOOD WITH THE CURRENT REPORTED DESCRIPTION. THE COMPLAINT HAS BEEN CONFIRMED WITHOUT A DEFINITIVE ROOT CAUSE ASSIGNMENT SINCE THERE IS INSUFFICIENT INFORMATION AVAILABLE TO DETERMINE A ROOT CAUSE. A DIMENSIONAL INSPECTION WAS NOT REQUIRED DUE TO THE NATURE OF THE COMPLAINT. OTHER REMARKS: THE DEVICE HISTORY RECORD WAS REVIEWED WITH NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. THE COMPLAINT HAS BEEN CONFIRMED STRICTLY FROM VISUAL INSPECTION OF THE COMPLAINT SAMPLE. THE LACK OF DOCUMENTED DETAIL AND/OR PICTURES OF THE INCIDENT PREVENTS A DEFINITIVE ROOT CAUSE ASSIGNMENT. NO CORRECTIVE/PREVENTATIVE ACTIONS WILL BE ASSIGNED. THE COMPLAINT HAS BEEN CONFIRMED STRICTLY FROM A VISUAL INSPECTION PERSPECTIVE. CLOSE UP PHOTOS REVEAL THE TWISTED METAL END OF THE LESION BIOPSY NEEDLE. OBVIOUSLY, THE BIOPSY NEEDLE WAS IN A VERY HARD MATTER, BUT WHETHER OR NOT THE PROPER NEEDLE RETRIEVAL TECHNIQUE WAS PRACTICED, OR IF THE CORRECT MANUAL NEEDLE REMOVAL TECHNIQUE TO REMOVE A NEEDLE WAS EXECUTED CANNOT BE DETERMINED. THE DEVICE HISTORY RECORD AND COFC WERE REVIEWED AND THERE WAS NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED.
IT WAS REPORTED THAT THE PATIENT WAS NOT HARMED SPEAKING WITH PHYSICIAN, PIECE OF BIOPSY DEVICE BROKE OFF INSIDE OF PATIENT BONE THAT WAS BEING BIOPSIED, LOCATION IS SAFE (ILIUM/ILIAC CREST) AND SHOULD NOT AFFECT PATIENT IN ANYWAY (SIMILAR TO ORTHO SCREW BEING PLACED), PATIENT MADE AWARE THAT THIS PIECE OF DEVICE WAS LEFT IN THE BONE AND FULLY UNDERSTOOD, ANOTHER DEVICE WAS USED TO SUCCESSFULLY ACHIEVE THE SAMPLE.
IT WAS REPORTED THAT THE PATIENT WAS NOT HARMED SPEAKING WITH PHYSICIAN, PIECE OF BIOPSY DEVICE BROKE OFF INSIDE OF PATIENT BONE THAT WAS BEING BIOPSIED, LOCATION IS SAFE (ILIUM/ILIAC CREST) AND SHOULD NOT AFFECT PATIENT IN ANYWAY (SIMILAR TO ORTHO SCREW BEING PLACED), PATIENT MADE AWARE THAT THIS PIECE OF DEVICE WAS LEFT IN THE BONE AND FULLY UNDERSTOOD, ANOTHER DEVICE WAS USED TO SUCCESSFULLY ACHIEVE THE SAMPLE.
(B)(4). THE DEVICE INVESTIGATION IS PENDING. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.
IT WAS REPORTED THAT THE PATIENT WAS NOT HARMED SPEAKING WITH PHYSICIAN, PIECE OF BIOPSY DEVICE BROKE OFF INSIDE OF PATIENT BONE THAT WAS BEING BIOPSIED, LOCATION IS SAFE (ILIUM/ILIAC CREST) AND SHOULD NOT AFFECT PATIENT IN ANYWAY (SIMILAR TO ORTHO SCREW BEING PLACED), PATIENT MADE AWARE THAT THIS PIECE OF DEVICE WAS LEFT IN THE BONE AND FULLY UNDERSTOOD, ANOTHER DEVICE WAS USED TO SUCCESSFULLY ACHIEVE THE SAMPLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1112102 | ONCONTROL COAXIAL BIOPSY TRAY 11/13 GA | BIOPSY NEEDLE KIT | FCG | TELEFLEX MEDICAL | 32967451 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |