ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE
Report
- Report Number
- 3001845648-2023-00462
- Event Type
- Injury
- Date Received
- June 13, 2023
- Date of Event
- May 12, 2023
- Report Date
- July 26, 2023
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FCG
- UDI-DI
- 10827002557366
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PMA/510(K) # K210476; INVESTIGATION IS STILL PENDING, A FOLLOW-UP MDR REPORT WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
PMA/510(K) # K210476. DEVICE EVALUATION: THE ECHO-HD-22-C DEVICE OF LOT NUMBER C2016685 INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION OPENED, WITH ITS ORIGINAL PACKAGING. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON 22 JUNE 2023. CLARIFICATION WAS REQUESTED ON THE KINKS OBSERVED AFTER LAB EVALUATION AND THE CUSTOMER CONFIRMED THAT THE KINKS WERE OBSERVED PRIOR TO SHIPPING DEVICE BACK TO CIRL AS WELL AS AFTER PROCEDURE. ON EVALUATION THE BELOW OBSERVATIONS WERE MADE: STYLET NOT RETURNED, DISTAL END OF NEEDLE EXAMINED AND DISTAL KINK OBSERVED NEAR THE NOTCH APPROX. 0.5CM FROM TIP OF NEEDLE (IPE OF RULER USED IPE 0402), PROXIMAL KINK BELOW THE SHEATH EXTENDER OBSERVED, NEEDLE REMOVED FROM THE DEVICE WITH SLIGHT DIFFICULTY AND MULTIPLE KINKS OBSERVED, SECOND KINK APPROX. 58.5CM FROM HUB OF NEEDLE, THIRD KINK APPROX. 93CM FROM HUB OF NEEDLE, SHEATH EXTENDER ABLE TO ADVANCE AND RETRACT WITH NO ISSUE, NEEDLE ABLE TO ADVANCE WITH SLIGHT DIFFICULTY AND UNABLE TO RETRACT FULLY INTO THE SHEATH. A LAB RE- EVALUATION WAS DONE ON 6 JULY 2023. THE PROXIMAL KINK BELOW THE SHEATH EXTENDER WAS EXAMINED AND OBSERVED TO BE APPROX. 4CM FROM THE TIP OF THE EXTENDED MLLA (IPE OF RULER USED IPE 0402). MANUFACTURING RECORDS: PRIOR TO DISTRIBUTION, ALL DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR ECHO-HD-22-C OF LOT NUMBER C2016685 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. REVIEW HISTORICAL DATA: THE REVIEW OF RELEVANT MANUFACTURING RECORDS CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED WITH LOT NUMBER C2016685. 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.¿ THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER COMPLAINT COULD NOT BE DETERMINED AS CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN THE LABORATORY. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO THE DISTAL KINK OCCURRING AFTER THE NEEDLE ENCOUNTERED A HARD LESION OR MASS, IT IS STATED IN THE ADDITIONAL INFORMATION THAT DEVICE WAS USED IN A TORTUOUS POSITION. IT IS ALSO STATED IN THE ADDITIONAL INFORMATION THAT DIFFICULTY WAS EXPERIENCED WHILE RETRACTING THE NEEDLE AS THE NEEDLE WAS BENT/KINKED, THIS RETRACTION DIFFICULTY COULD HAVE CONTRIBUTED TO THE MULTIPLE KINKS OBSERVED ON THE NEEDLE. CONFIRMATION OF COMPLAINT: COMPLAINT IS CONFIRMED BASED ON VISUAL AND/OR FUNCTIONAL INSPECTION. 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 BENT DURING INTERVENTION AND THE PATIENT WAS INJURED. CONFIRMED QUANTITY OF 01 DEVICE, CONFIRMED USED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID EXPERIENCE ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE PATIENT WAS IN THE EMERGENCY ROOM WITH A HEMATOMA. INVESTIGATION FINDINGS CONCLUDE THAT A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO THE DISTAL KINK OCCURRING AFTER THE NEEDLE ENCOUNTERED A HARD LESION OR MASS, IT IS STATED IN THE ADDITIONAL INFORMATION THAT DEVICE WAS USED IN A TORTUOUS POSITION. COMPLAINT IS CONFIRMED BASED ON VISUAL AND/OR FUNCTIONAL INSPECTION.
PMA/510(K) # K210476; INVESTIGATION IS STILL PENDING, A FOLLOW-UP MDR REPORT WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
THIS FOLLOW UP MDR IS BEING SUBMITTED TO CAPTURE THE LAB EVALUATIONS CONDUCTED ON 22-JUN-2023 AND 06-JUL-2023. ADDITIONAL INFORMATION RECEIVED ON 06-JUL-2023: 1. THE KINKS WERE OBSERVED PRIOR TO THE DEVICE SHIPPED BACK TO COOK IRELAND. 2. THEY WERE OBSERVED AFTER PROCEDURE.
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.
PER REP PHONE CALL: " THE NEEDLE BENT DURING INTERVENTION AND THE PATIENT WAS DAMAGED (INJURED). " "AS PER CC FORM": THE NEEDLE BENDED DURING INTERVENTION AND THE PATIENT WAS DAMAGED PATIENT OUTCOME: A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE PATIENT WAS IN THE EMERGENCY ROOM WITH A HEMATOMA. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE EMERGENCY ROOM WITH A HEMATOMA. 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))? PATIENT END 3. WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DEVICE PRIOR TO RETURN (E.G. KINK)? NO 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? . NO 5. IF THE DEVICE IS A PROCORE NEEDLE, IS THE DEVICE DAMAGE LOCATED AT THE NOTCH / CORE TRAP? CORE TRAP IF NO, PLEASE SPECIFY WHERE THE DAMAGE IS LOCATED: _____________________ 6. WAS GAINING ACCESS TO THE TARGET SITE DIFFICULT? NO 7. WAS THE DEVICE USED IN A TORTUOUS POSITION? . YES 8. WAS PUNCTURE OF THE TARGET SITE DIFFICULT? NO 9. PLEASE DESCRIBE THE ANATOMICAL LOCATION OF THE INTENDED TARGET SITE (PANCREAS, STOMACH, LUNGS ETC.). DUODENUM 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? 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? YES 15. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES AS A RESULT OF THIS EVENT? YES 16. WHAT INTERVENTION (IF ANY) WAS REQUIRED? ANOTHER PUNCTION AND EMERGENCY ROOM 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? OLYMPUS 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? 24. WAS THE SYRINGE USED DURING THE PROCEDURE, AFTER THE STYLET WAS REMOVED? YES 25. WAS DIFFICULTY EXPERIENCED WHILE RETRACTING THE NEEDLE? YES BECAUSE THE NEEDLE WAS BENT 26. WAS IT POSSIBLE TO FULLY RETRACT THE NEEDLE INTO THE SHEATH BEFORE REMOVING THE DEVICE FROM THE PATIENT? NO 27. WAS THE ENDOSCOPE IN A FLEXED OR TWISTED POSITION AT ANY TIME DURING THE PROCEDURE? N/A,YES,NO. 28. WAS THE STYLET PARTIALLY REMOVED WHEN ADVANCING THE NEEDLE INTO THE TARGET SITE? NO 29. HOW MANY SAMPLES WERE OBTAINED (PASSES COMPLETED) WITH THIS NEEDLE? 30. DID ANY SECTION OF THE DEVICE DETACH INSIDE THE PATIENT? NO IF YES, PLEASE SPECIFY: 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? N/A, YES, 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, YES, NO 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 |
|---|---|---|---|---|---|---|---|
| 2190233 | ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE | FCG KIT, NEEDLE, BIOPSY | FCG | COOK IRELAND LTD | C2016685 | 10827002557366 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |