ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE
Report
- Report Number
- 3001845648-2023-00281
- Event Type
- Malfunction
- Date Received
- April 28, 2023
- Report Date
- August 2, 2023
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FCG
- UDI-DI
- 10827002347851
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
PMA/510(K) # K210476. DEVICE EVALUATION: 1 UNIT OF LOT C1994672 OF ECHO-HD-3-20-C WAS RETURNED TO CIRL 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 26 APR 2023. PROXIMAL KINK OBSERVED BELOW SHEATH EXTENDER. NEEDLE REMOVED FROM DEVICE AND PROXIMAL BREAK OBSERVED. 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 DEVICE OF LOT NUMBER C1994672 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 C1994672. 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. (IFU0077). IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN THE LABORATORY. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO THE DEVICE BEING USED IN A FLEXED/TWISTED POSITION AS INDICATED BY Q.6 OF THE ADDITIONAL INFORMATION DURING THE PROCEDURE OR EXCESSIVE FORCE WHICH CAN BE APPLIED WHEN TRYING TO GET THE NEEDLE OUT OF THE SCOPE DURING ADVANCEMENT POTENTIALLY CAUSING THE NEEDLE TO KINK/ BREAK AND UNABLE TO RETRACT INTO THE SHEATH . CONFIRMATION OF COMPLAINT: COMPLAINT IS CONFIRMED BASED ON VISUAL AND/OR FUNCTIONAL INSPECTION. CORRECTIVE ACTION/CORRECTION: ALL LOTS MANUFACTURED FROM THE 10TH/11TH MAY 2022 HAVE THE CAPA IMPROVEMENTS. AS A RESULT, CLARIFICATION WAS REQUESTED FROM QA ENGINEERING TO DETERMINE IF CAPA 217973 IS INEFFECTIVE OR IF A NEW CAPA NEEDS TO BE RAISED AND IT WAS CONCLUDED THAT THE ISSUE DOES NOT FALL UNDER CAPA PR 217973 SO NO ACTION IS NECESSARY. SUMMARY OF INVESTIGATION: ACCORDING TO THE CUSTOMER, THE NEEDLE WAS BROKEN 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 POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO THE DEVICE BEING USED IN A FLEXED/TWISTED POSITION AS INDICATED BY Q.6 OF THE ADDITIONAL INFORMATION DURING THE PROCEDURE OR EXCESSIVE FORCE WHICH CAN BE APPLIED WHEN TRYING TO GET THE NEEDLE OUT OF THE SCOPE DURING ADVANCEMENT POTENTIALLY CAUSING THE NEEDLE TO KINK/BREAK AND UNABLE TO RETRACT INTO THE SHEATH.
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. INVESTIGATION IS STILL PENDING, A FOLLOW-UP MDR REPORT WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
THIS FOLLOW UP MDR IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON THE 02-AUG-2023.
THIS FOLLOW UP MDR IS BEING SUBMITTED TO CAPTURE THE LAB EVALUATION CONDUCTED ON 26-APR-2023.
USER DETECTED THE STYLET CANNOT BE RETRACTED INTO SHEATH AFTER BIOPSY AND FOUND OUT THE STYLET BROKEN. 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: FOR COMPLAINTS OCCURRING DURING USE (ONCE IN CONTACT WITH ENDOSCOPE) ALSO ASK: 1. IF THE REPORT INVOLVES A KINK OR BEND IN THE NEEDLE, WHERE IS THIS LOCATED ON THE DEVICE (HANDLE END OR PATIENT END)? HANDLE END. 2. PLEASE DESCRIBE THE LOCATION IN THE BODY FOR THE INTENDED TARGET SITE (PANCREAS, STOMACH, ETC). PANCREAS. 3. PLEASE DESCRIBE THE SIZE OF THE INTENDED TARGET SITE. 2X3 CM 2X3CM. 4. WHAT IS THE ENDOSCOPE MANUFACTURER AND MODEL NUMBER THAT WAS USED WITH THIS DEVICE? OLYMPUS 290. 290. 5. WAS GAINING ACCESS TO THE TARGETED SITE DIFFICULT? NO. 6. WAS THE ENDOSCOPE IN A FLEXED OR TWISTED POSITION AT ANY TIME DURING THE PROCEDURE? YES 7. WAS NEEDLE PENETRATION OF THE TARGETED SITE DIFFICULT? NO. 8. WAS THE STYLET IN PLACE INSIDE THE NEEDLE WHEN ADVANCING INTO THE TARGETED SITE? YES 9. HOW MANY BIOPSIES WERE OBTAINED WITH USE OF THIS NEEDLE? 1 10. DID ANY SECTION OF THE DEVICE DETACH INSIDE THE PATIENT? NO. 11. IF NOT WITH THE DEVICE IN QUESTION, HOW WAS THE PROCEDURE PERFORMED AND/OR FINISHED? WITH ANOTHER SAME DEVICE TO COMPLETE THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 429316 | ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE | FCG KIT, NEEDLE, BIOPSY | FCG | COOK IRELAND LTD | C1994672 | 10827002347851 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |