ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE
Report
- Report Number
- 3001845648-2023-00439
- Event Type
- Injury
- Date Received
- June 2, 2023
- Date of Event
- May 3, 2023
- Report Date
- July 13, 2023
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FCG
- UDI-DI
- 10827002347851
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
PMA/510(K) #K210476. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
PMA/510(K) #K210476. DEVICE EVALUATION: 1 UNIT OF LOT NUMBER C2018368 OF ECHO-HD-3-20-C WAS RETURNED OPENED IN ITS ORIGINAL PACKAGING. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT BASED INVESTIGATION WAS CONDUCTED. THE DEVICE INVOLVED IN THE COMPLAINT WAS EVALUATED IN THE LABORATORY ON 08 JUN 2023. DISTAL END OF NEEDLE EXAMINED AND DISTAL BREAK OBSERVED APPROXIMATELY 4 CM FROM TIP OF SHEATH. MANUFACTURING RECORDS: PRIOR TO DISTRIBUTION, ALL ECHO-HD-3-20-C DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR ECHO-HD-3-20-C OF LOT NUMBER C2018368 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. REVIEW HISTORICAL DATA: A REVIEW OF THE MANUFACTURING RECORDS FOR THE ECHO-HD-3-20-C DEVICE CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED WITH THE CURRENT LOT NUMBER. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C2018368. INSTRUCTIONS FOR USE AND LABEL: THE NOTES SECTION OF THE INSTRUCTIONS FOR USE (IFU0077), WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER TO INSPECT THE DEVICE PRIOR TO USE: "VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE" AND IN THE PRECAUTIONS SECTION "ENSURE THE STYLET IS FULLY INSERTED WHEN ADVANCING THE NEEDLE INTO THE BIOPSY SITE" . THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. (IFU0077). ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE COULD BE ATTRIBUTED TO USER ERROR AS THE STYLET SHOULD NOT BE PARTIALLY REMOVED PRIOR TO ADVANCEMENT OF THE NEEDLE INTO INTENDED TARGETED SITE. THE ANSWER TO Q.28 OF THE ADDITIONAL QUESTIONS INDICATES THAT THE STYLET WAS PARTIALLY REMOVED 1 OR 2CM WHEN ADVANCING INTO THE TARGET SITE. RETRACTING THE STYLET MAY HAVE CONTRIBUTED TO THE DISTAL NEEDLE BREAK THAT OCCURRED 4 CM FROM THE TIP OF THE SHEATH AS THE STYLET PROVIDES SUPPORT TO THE NEEDLE WHEN PUNCTURING THE TARGET SITE. CONFIRMATION OF COMPLAINT: COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY AND VERIFICATION IN THE LAB. CORRECTIVE ACTION/CORRECTION: COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS. SUMMARY OF INVESTIGATION: ACCORDING TO THE CUSTOMER, THE NEEDLE BROKE DURING THE PUNCTURE. CONFIRMED QUANTITY OF 1 DEVICE, CONFIRMED USED. ACCORDING TO THE INITIAL REPORT, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. INVESTIGATION FINDINGS CONCLUDE THAT A DEFINITIVE ROOT CAUSE COULD BE ATTRIBUTED TO USER ERROR AS THE STYLET SHOULD NOT BE PARTIALLY REMOVED PRIOR TO ADVANCEMENT OF THE NEEDLE INTO INTENDED TARGETED SITE. THE ANSWER TO Q.28 OF THE ADDITIONAL QUESTIONS INDICATES THAT THE STYLET WAS PARTIALLY REMOVED 1 OR 2CM WHEN ADVANCING INTO THE TARGET SITE. RETRACTING THE STYLET MAY HAVE CONTRIBUTED TO THE DISTAL NEEDLE BREAK THAT OCCURRED 4 CM FROM THE TIP OF THE SHEATH AS THE STYLET PROVIDES SUPPORT TO THE NEEDLE WHEN PUNCTURING THE TARGET SITE.
PMA/510(K) # K210476. INVESTIGATION IS STILL PENDING, A FOLLOW-UP MDR REPORT WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE LAB EVAL ON (B)(6)2023.
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 13-JUL-2023.
DURING A PUNCTURE USING A PROCORE ECHO-HD-3-20-C PUNCTURE NEEDLE, THE NEEDLE BROKE DURING THE PUNCTURE. THE TIP OF THE NEEDLE IS WITHDRAWN WITH FOREIGN BODY FORCEPS THROUGH THE WORKING CHANNEL AND HAS DAMAGED THE ENDOSCOPE. NO DIRECT AND INDIRECT PATIENT INJURY. NO LOT # WAS PROVIDED, EMAIL SENT TO THE CUSTOMER AND REP TO PROVIDE THE LOT NUMBER "AS PER CC FORM": DURING A PUNCTURE USING A PROCORE ECHO-HD-3-20-C PUNCTURE NEEDLE, THE NEEDLE BROKE DURING THE PUNCTURE. THE TIP OF THE NEEDLE IS WITHDRAWN WITH FOREIGN BODY FORCEPS THROUGH THE WORKING CHANNEL AND HAS DAMAGED THE ENDOSCOPE. NO DIRECT AND INDIRECT PATIENT INJURY. PATIENT OUTCOME: A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE PATIENT/EVENT INFO - NOTES: 1. ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? NO 2. IF THE REPORT INVOLVES A KINK OR BEND IN THE NEEDLE, WHERE IS THIS LOCATED ON THE DEVICE (HANDLE END (PROXIMAL END) OR PATIENT END (DISTAL END))? N/A, 3. WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DEVICE PRIOR TO RETURN (E.G. KINK)? N/A PLEASE SPECIFY IF YES. 4. IF THE DEVICE WAS KINKED BELOW THE SHEATH EXTENDER, WAS THE KINK OBSERVED BEFORE INSERTING THE DEVICE INTO THE SCOPE? N/A, 5. IF THE DEVICE IS A PROCORE NEEDLE, IS THE DEVICE DAMAGE LOCATED AT THE NOTCH / CORE TRAP? NO IF NO, PLEASE SPECIFY WHERE THE DAMAGE IS LOCATED: NEEDLE BROKEN AT 4 OR 5 CM AT THE NEEDLE END. 6. WAS GAINING ACCESS TO THE TARGET SITE DIFFICULT? NO, ACCESS DIRECT IN THE STOMACH 7. WAS THE DEVICE USED IN A TORTUOUS POSITION? NO 8. WAS PUNCTURE OF THE TARGET SITE DIFFICULT? NO 9. PLEASE DESCRIBE THE ANATOMICAL LOCATION OF THE INTENDED TARGET SITE (PANCREAS, STOMACH, LUNGS ETC.). A. IF THE LUNGS, WHICH LYMPH NODE WAS BEING TARGETED? E.G. 4R, 11R, 12L ETC. 10. PLEASE DESCRIBE THE SIZE OF THE INTENDED TARGET SITE. 11. IF NOT WITH THE DEVICE IN QUESTION, HOW WAS THE PROCEDURE PERFORMED AND/OR FINISHED? STOP PROCEDURE 12. WAS THE DEVICE DAMAGED IN PACKAGING PRIOR TO REMOVAL? NO 13. WAS THE DEVICE DAMAGED ON REMOVAL FROM PACKAGING? NO 14. WAS FORCE REQUIRED TO REMOVE THE DEVICE? NO 15. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES AS A RESULT OF THIS EVENT? NO 16. WHAT INTERVENTION (IF ANY) WAS REQUIRED? 17. WAS THE SECONDARY INTERVENTION PERFORMED DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? N/A, 18. WERE ANY OTHER DEFECTS OBSERVED ON THE DEVICE PRIOR TO RETURN (E.G. KINKS, BENDS, BREAKS ETC.)? NO 19. IF YES, PLEASE SPECIFY WHAT WAS OBSERVED AND WHERE ON THE DEVICE IT WAS OBSERVED. 20. WHAT IS THE SCOPE MANUFACTURER AND MODEL NUMBER THAT WAS USED? EG38-J 0UT N° SÉRIE A120096 ECHOENDOSCOPE PENTAX 21. WAS RESISTANCE FELT WHILE INSERTING THE DEVICE THROUGH THE SCOPE? NO 22. WAS THE SCOPE RECENTLY SERVICED / REPAIRED? YES, 23. WHEN WAS THE ISSUED WITH THE PRODUCT NOTED? ON NEEDLE RETRACTION? 24. WAS THE SYRINGE USED DURING THE PROCEDURE, AFTER THE STYLET WAS REMOVED? N/A 25. WAS DIFFICULTY EXPERIENCED WHILE RETRACTING THE NEEDLE? YES 26. WAS IT POSSIBLE TO FULLY RETRACT THE NEEDLE INTO THE SHEATH BEFORE REMOVING THE DEVICE FROM THE PATIENT? YES, BUT THE NEEDLE IS BROKEN AND THE NEEDLE END IS IN THE STOMACH 27. WAS THE ENDOSCOPE IN A FLEXED OR TWISTED POSITION AT ANY TIME DURING THE PROCEDURE?, NO 28. WAS THE STYLET PARTIALLY REMOVED WHEN ADVANCING THE NEEDLE INTO THE TARGET SITE? YES, 1 OR 2 CM 29. HOW MANY SAMPLES WERE OBTAINED (PASSES COMPLETED) WITH THIS NEEDLE? IT IS JUST THE FIRST PASS 30. DID ANY SECTION OF THE DEVICE DETACH INSIDE THE PATIENT? YES IF YES, PLEASE SPECIFY: THE NEEDLE HAS COME LOOSE IN THE STOMACH ON THE PUNCTURE POINT, THE DOCTOR TAKES FORCEPS TO DETACH THE END OF THE NEEDLE FROM THE STOMACH AND REMOVE IT THROUGH THE CHANNEL OF THE ENDOSCOPE BUT THE END OF THE NEEDLE IS IMPOSSIBLE TO GET OUT OF THE CHANNEL. 31. WAS THERE DIFFICULTY LOCKING THE SHEATH (OR NEEDLE) IN PLACE OR SLIPPING EXPERIENCED DURING USE? NO 32. WAS THERE DIFFICULTY IN ATTACHING OR DETACHING THE DEVICE TO THE ACCESSORY CHANNEL PORT ON THE SCOPE? NO 33. WHEN THE NEEDLE TIP WAS ADVANCED INTO THE TARGET SITE WAS THE DISTAL SCOPE POSITION ADJUSTED SO AS TO STRAIN OR FLEX THE NEEDLE? N/A, 34. IF AN EBUS PROCEDURE DID THE NEEDLE TIP HIT THE CARTILAGE RINGS OF THE TRACHEA? RESPONSE TO ADDITIONAL QUESTIONS FORM, ANSWERS HIGHLIGHTED/CROSSED OUT ON DOCUMENT IN ATTACHED EMAIL: 1. ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? NO 2. IF THE REPORT INVOLVES A KINK OR BEND IN THE NEEDLE, WHERE IS THIS LOCATED ON THE DEVICE (HANDLE END (PROXIMAL END) OR PATIENT END (DISTAL END))? N/A, 3. WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DEVICE PRIOR TO RETURN (E.G. KINK)? N/A PLEASE SPECIFY IF YES. 4. IF THE DEVICE WAS KINKED BELOW THE SHEATH EXTENDER, WAS THE KINK OBSERVED BEFORE INSERTING THE DEVICE INTO THE SCOPE? N/A, 5. IF THE DEVICE IS A PROCORE NEEDLE, IS THE DEVICE DAMAGE LOCATED AT THE NOTCH / CORE TRAP? NO IF NO, PLEASE SPECIFY WHERE THE DAMAGE IS LOCATED: NEEDLE BROKEN AT 4 OR 5 CM AT THE NEEDLE END. 6. WAS GAINING ACCESS TO THE TARGET SITE DIFFICULT? NOT DIFFICULTY BUT TWISTING THE END OF THE ENDOSCOPE AND PRESSING THE SMALL CURVATURE OF THE STOMACH. WHEN FANNING USING THE ERECTOR OF THE ENDOSCOPIC ULTRASOUND. 7. WAS THE DEVICE USED IN A TORTUOUS POSITION? NO 8. WAS PUNCTURE OF THE TARGET SITE DIFFICULT? NO 9. PLEASE DESCRIBE THE ANATOMICAL LOCATION OF THE INTENDED TARGET SITE (PANCREAS, STOMACH, LUNGS ETC.). TUMOR MASS MIDDLE PANCREAS (PANCREAS BODY) A. IF THE LUNGS, WHICH LYMPH NODE WAS BEING TARGETED? E.G. 4R, 11R, 12L ETC. 10. PLEASE DESCRIBE THE SIZE OF THE INTENDED TARGET SITE. 2 OR 3CM TUMOR 11. IF NOT WITH THE DEVICE IN QUESTION, HOW WAS THE PROCEDURE PERFORMED AND/OR FINISHED? STOP PROCEDURE 12. WAS THE DEVICE DAMAGED IN PACKAGING PRIOR TO REMOVAL? NO 13. WAS THE DEVICE DAMAGED ON REMOVAL FROM PACKAGING? NO 14. WAS FORCE REQUIRED TO REMOVE THE DEVICE? NO 15. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES AS A RESULT OF THIS EVENT? NO, BECAUSE THERE WERE 2 PASSES WITH THIS NEEDLE AND THERE WERE TUMOR SAMPLES IN THE 1ST PASS. 16. WHAT INTERVENTION (IF ANY) WAS REQUIRED? 17. WAS THE SECONDARY INTERVENTION PERFORMED DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? NO 18. WERE ANY OTHER DEFECTS OBSERVED ON THE DEVICE PRIOR TO RETURN (E.G. KINKS, BENDS, BREAKS ETC.)? NO 19. IF YES, PLEASE SPECIFY WHAT WAS OBSERVED AND WHERE ON THE DEVICE IT WAS OBSERVED. 20. WHAT IS THE SCOPE MANUFACTURER AND MODEL NUMBER THAT WAS USED? EG38-J 0UT N° SÉRIE A120096 ECHOENDOSCOPE PENTAX 21. WAS RESISTANCE FELT WHILE INSERTING THE DEVICE THROUGH THE SCOPE? NO 22. WAS THE SCOPE RECENTLY SERVICED / REPAIRED? YES, 23. WHEN WAS THE ISSUED WITH THE PRODUCT NOTED? ON NEEDLE RETRACTION? 24. WAS THE SYRINGE USED DURING THE PROCEDURE, AFTER THE STYLET WAS REMOVED? N/A 25. WAS DIFFICULTY EXPERIENCED WHILE RETRACTING THE NEEDLE? YES 26. WAS IT POSSIBLE TO FULLY RETRACT THE NEEDLE INTO THE SHEATH BEFORE REMOVING THE DEVICE FROM THE PATIENT? YES, BUT THE NEEDLE IS BROKEN AND THE NEEDLE END IS IN THE STOMACH 27. WAS THE ENDOSCOPE IN A FLEXED OR TWISTED POSITION AT ANY TIME DURING THE PROCEDURE?, NO 28. WAS THE STYLET PARTIALLY REMOVED WHEN ADVANCING THE NEEDLE INTO THE TARGET SITE? YES, 1 OR 2 CM 29. HOW MANY SAMPLES WERE OBTAINED (PASSES COMPLETED) WITH THIS NEEDLE? IT IS JUST THE FIRST PASS 30. DID ANY SECTION OF THE DEVICE DETACH INSIDE THE PATIENT? YES IF YES, PLEASE SPECIFY: THE NEEDLE HAS COME LOOSE IN THE STOMACH ON THE PUNCTURE POINT, THE DOCTOR TAKES FORCEPS TO DETACH THE END OF THE NEEDLE FROM THE STOMACH AND REMOVE IT THROUGH THE CHANNEL OF THE ENDOSCOPE BUT THE END OF THE NEEDLE IS IMPOSSIBLE TO GET OUT OF THE CHANNEL. THE NEEDLE IS STUCK IN THE ENDOSCOPE 31. WAS THERE DIFFICULTY LOCKING THE SHEATH (OR NEEDLE) IN PLACE OR SLIPPING EXPERIENCED DURING USE? NO 32. WAS THERE DIFFICULTY IN ATTACHING OR DETACHING THE DEVICE TO THE ACCESSORY CHANNEL PORT ON THE SCOPE? NO 33. WHEN THE NEEDLE TIP WAS ADVANCED INTO THE TARGET SITE WAS THE DISTAL SCOPE POSITION ADJUSTED SO AS TO STRAIN OR FLEX THE NEEDLE? N/A, 34. IF AN EBUS PROCEDURE DID THE NEEDLE TIP HIT THE CARTILAGE RINGS OF THE TRACHEA?
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1648429 | ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE | FCG KIT, NEEDLE, BIOPSY | FCG | COOK IRELAND LTD | C2018368 | 10827002347851 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |