ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE
Report
- Report Number
- 3001845648-2024-00590
- Event Type
- Injury
- Date Received
- October 7, 2024
- Date of Event
- September 9, 2024
- Report Date
- January 14, 2025
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FCG
- UDI-DI
- 10827002342818
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DE, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PMA/510(K): K210476. DEVICE EVALUATION: 1 UNIT OF LOT C2132141 OF ECHO-HD-22-EBUS-O-C WAS RETURNED OPENED NOT IN ITS ORIGINAL PACKAGING. IT SHOULD BE NOTED THAT THIS FILE IS RELATED TO ANOTHER COMPLAINT FILE. FOR DETAILS OF THE OTHER INVESTIGATION PLEASE REFER TO (B)(4). THROUGH THE INVESTIGATION IT WAS CONFIRMED THAT ANOTHER SIMILAR CASE HAD TAKEN PLACE ONE WEEK BEFORE WHICH WILL BE INVESTIGATED UNDER RELATED (B)(4). THE LOT NUMBER OF THE DEVICE USED UNDER RELATED (B)(4) COULD NOT BE CONFIRMED. MANUFACTURING RECORDS: PRIOR TO DISTRIBUTION, ALL ECHO-HD-22-EBUS-O-C DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR ECHO-HD-22-EBUS-O-C OF LOT NUMBER C2132141 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. INSTRUCTIONS FOR USE AND/LABEL. THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, IFU0109 WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER TO; "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 "THIS DEVICE IS INTENDED FOR USE WITH AN OLYMPUS EBUS SCOPE". THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE IN RELATION TO THE TYPE OF SCOPE USED (IFU0109). IMAGE REVIEW: AN IMAGE WAS PROVIDED TO SUPPORT THE COMPLAINT INVESTIGATION. THIS WAS REVIEWED THROUGH COOK RESEARCH INC. (CRI) AND THE FOLLOWING COMMENTS WERE PROVIDED BY THE INDEPENDENT REVIEWER: 1. THE ECHOTIP PROCORE NEEDLE WAS BEING USED DURING AN EBUS PROCEDURE THROUGH A FUJI SCOPE, WHICH IS OFF-LABEL, PER THE REPORT. IT WAS NOTED THAT THERE IS SIGNIFICANTLY MORE RESISTANCE TO ADVANCE THE NEEDLE THROUGH THE FUJI SCOPE WHEN COMPARED TO THE OLYMPUS NEEDLE. THIS EXTRA FORCE, IN ADDITION TO THE INCREASED ABILITY TO ¿BEND¿ THE FUJI SCOPE MAY HAVE LET TO FOCAL WEAKENING OF THE PROCORE NEEDLE CONTRIBUTING TO ITS FRACTURE. THE REPORT ALSO MAKES REFERENCE TO ANOTHER INCIDENT OF THIS OCCURRING WITH THE SAME EQUIPMENT ON A DIFFERENT SETTING SUPPORTS THIS THEORY. 2. FORTUNATELY, THE FRACTURED FRAGMENT WAS RETRIEVED USING FORCEPS WITHOUT PERMANENT INJURY TO THE PATIENT. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE COULD BE ATTRIBUTED TO USER ERROR AS THE USER USED THE DEVICE WITH AN INCOMPATIBLE DEVICE, AS PER INFORMATION PROVIDED, A FUJI SCOPE WAS USED AND AS PER IFU ¿THIS DEVICE IS INTENDED FOR USE WITH AN OLYMPUS EBUS SCOPE¿, THEREFORE THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. IT IS NOT POSSIBLE TO KNOW HOW THE DEVICE PERFORMS WITH AN INCOMPATIBLE DEVICE THEREFORE THE DISTAL NEEDLE BREAK AND KINK ENCOUNTERED BY THE USER AND OBSERVED DURING THE LAB EVALUATION COULD HAVE BEEN INDUCED BY THE SCOPE. AS PER IMAGE REVIEW FEEDBACK EXTRA FORCE IN ADDITION TO THE INCREASED ABILITY TO ¿BEND¿ THE FUJI SCOPE MAY HAVE LET TO FOCAL WEAKENING OF THE NEEDLE CONTRIBUTING TO ITS FRACTURE. SUMMARY: COMPLAINT IS CONFIRMED BASED ON VISUAL AND/OR FUNCTIONAL INSPECTION. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. AFTER GETTING OUT THE NEEDLE TIP WITH A FORCEPS, THE EBUS CASE WAS FINISHED WITH AN OLYMPUS NEEDLE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS.
PMA/510(K): K210476. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE A CODE UPDATED BASED ON ADDITIONAL INFORMATION RECEIVED ON (B)(6)2025 AND THE COMPLETION OF THE INVESTIGATION ON (B)(6)2025.
REP WAS INFORMED THAT IN 2 CASES THE TIP OF THE NEEDLE BROKE OFF, 1 PIECE AVAILABLE FOR EVALUATION THE OTHER WAS SCRAPPED. AS PER CC FORM: DURING EBUS PROCEDURE NEEDLE TIP BROKE OFF AND WAS GET OUT OF THE LUNG WITH A FORCEPS. A SECTION OF THE DEVICE DID REMAIN INSIDE THE PATIENT¿S BODY. NEEDLE TIP REMAIN IN THE LUNG BUT PUT OUT WITH A FORCEP. THE PATIENT DID REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. AFTER GETTING OUT THE NEEDLE TIP WITH A FORCEPS, THE EBUS CASE WAS FINISHED WITH AN OLYMPUS NEEDLE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. REP IS STILL WAITING ON THE ANSWERS TO YOUR ADDITIONAL QUESTIONS BUT HOPEFULLY, I'LL GET IT FROM THE CUSTOMER TOMORROW. THE CUSTOMER IS INFORMED ABOUT THE OFF-LABEL USE OF OUR NEEDLE WITH THE FUJI SCOPE. HE USES THIS COMBINATION OVER ONE YEAR AND NOW, HE HAD TWO CASES WITH BROKEN TIPS. BUT I CAN ONLY SEND ONE NEEDLE BACK. THE OTHER ONE WAS THROWN AWAY. ADDITIONAL INFORMATION FROM THE CUSTOMER: YOU HAVE TO APPLY MORE STRENGTH TO PUT OUR COOK NEEDLE THROUGH THE EBUS-SCOPE CHANNEL IN COMPARISON TO OLY EBUS (OR OLY NEEDLES WITH FUJI). IT SEEMS THAT THE EBUS TRANSDUCER HAS A DIFFERENT SIZE TO OLY EBUS SCOPES SO THAT YOU HAVE TO APPLY MORE STRENGTH TO PUT OUR SHEET OUT OF THE EBUS SCOPE ¿OVER¿ THE TRANSDUCER YOU CAN BEND THE FUJI EBUS SCOPE MORE THAN THE OLY EBUS SCOPE, THAT´S WHY IT COULD BE THE REASON FOR THE COMPLAINT (BROKEN NEEDLE TIP WITH OUR PROCORE) WHICH OCCURRED 1. ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? YES. 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))? BROKEN NEEDLE TIP. 3. WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DEVICE PRIOR TO RETURN (E.G. KINK)? NO. 4. IF THE DEVICE WAS KINKED BELOW THE SHEATH EXTENDER, WAS THE KINK OBSERVED BEFORE INSERTING THE DEVICE INTO THE SCOPE? NO. 5. IF THE DEVICE IS A PROCORE NEEDLE, IS THE DEVICE DAMAGE LOCATED AT THE NOTCH / CORE TRAP? YES. 6. WAS GAINING ACCESS TO THE TARGET SITE DIFFICULT? NO. 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? LK4. 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? IT WAS FINISHED WITH A OLYMPUS EBUS NEEDLE. 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? YES. 16. WHAT INTERVENTION (IF ANY) WAS REQUIRED? ¿ GET OUT THE NEEDLE TIP FROM THE LYMPH NODE WITH FORCEPS. 17. WAS THE SECONDARY INTERVENTION PERFORMED DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? SAME PROCEDURE. 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? FUJI EBUS SCOPE. 21. WAS RESISTANCE FELT WHILE INSERTING THE DEVICE THROUGH THE SCOPE? NO. 22. WAS THE SCOPE RECENTLY SERVICED / REPAIRED? NO. 23. WHEN WAS THE ISSUED WITH THE PRODUCT NOTED? ON ADVANCEMENT OF THE SHEATH/NEEDLE OR ON NEEDLE RETRACTION? BETWEEN THE FIRST AND SECOND. 24. WAS THE SYRINGE USED DURING THE PROCEDURE, AFTER THE STYLET WAS REMOVED? NO. 25. WAS DIFFICULTY EXPERIENCED WHILE RETRACTING THE NEEDLE? NO. 26. WAS IT POSSIBLE TO FULLY RETRACT THE NEEDLE INTO THE SHEATH BEFORE REMOVING THE DEVICE FROM THE PATIENT? N/A. 27. WAS THE ENDOSCOPE IN A FLEXED OR TWISTED POSITION AT ANY TIME DURING THE PROCEDURE? YES. 28. WAS THE STYLET PARTIALLY REMOVED WHEN ADVANCING THE NEEDLE INTO THE TARGET SITE? N/A. 29. HOW MANY SAMPLES WERE OBTAINED (PASSES COMPLETED) WITH THIS NEEDLE? 30. DID ANY SECTION OF THE DEVICE DETACH INSIDE THE PATIENT? YES. IF YES, PLEASE SPECIFY: THE NEEDLE TIP WHICH WAS GET OUT WITH FORCEPES. 31. WAS THERE DIFFICULTY LOCKING THE SHEATH (OR NEEDLE) IN PLACE OR SLIPPING EXPERIENCED DURING USE? N/A. 32. WAS THERE DIFFICULTY IN ATTACHING OR DETACHING THE DEVICE TO THE ACCESSORY CHANNEL PORT ON THE SCOPE? N/A. 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? NO.
SUPPLEMENTAL CORRECTION REPORT BEING SUBMITTED TO UPDATE A CODE BASED ON ADDITIONAL INFORMATION RECEIVED ON 12-DEC-2024.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 265561 | ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE | FCG KIT, NEEDLE, BIOPSY | FCG | COOK IRELAND LTD | C2196651 | 10827002342818 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Required Intervention |