ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE
Report
- Report Number
- 3001845648-2018-00130
- Event Type
- Malfunction
- Date Received
- March 16, 2018
- Date of Event
- January 24, 2018
- Report Date
- March 16, 2018
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FCG
- UDI-DI
- 00827002347854
- Report Source
- Manufacturer report
- Reporter Location
- KR
- Reporter Occupation
- NURSE
Narratives
510(K) NUMBER: K142688. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G. 1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4). COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
510(K) NUMBER: K142688. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031 . INFORMATION PERTAINING (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). DEVICE EVALUATION: THE ECHO-HD-3-20-C DEVICE OF LOT NUMBER C1274102 INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, WITH THE ORIGINAL PACKAGING. THE PACKAGING WAS OPEN ON RECEIPT. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT BASED INVESTIGATION WAS CONDUCTED. FROM CUSTOMER TESTIMONY, THE NEEDLE WAS FULLY RETRACTED WHEN REMOVING IT FROM THE PATIENT. THE PRODUCT WAS REMOVED TO THE SCOPE AND THE NURSE WITHDREW THE NEEDLE. THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION, THE DEVICE WAS RETURNED IN ITS ORIGINAL PACKAGING, THE SYRINGE WAS RETURNED. THE STYLET WAS PARTIALLY OUT, THERE WAS NO NEEDLE EXPOSURE. THE NEEDLE ADVANCES AND RETRACTS WITHOUT ISSUE. NEEDLE TIP IS INTACT. IT WAS NOTED THAT THE LUER IS SLIGHTLY OFF CENTRE, HOWEVER NO IMPACT ON FUNCTIONALITY. STYLET FULLY INSERTS, HOWEVER SLIGHTLY STIFF WHERE KINK IS PRESENT, AT THE DISTAL END. IT WAS FOUND THAT THE KINK WAS APPROXIMATELY 114CM FROM CANNULA. THE CUSTOMER COMPLAINT IS CONSIDERED TO BE CONFIRMED BASED ON LABORATORY FINDINGS. IT WAS FOUND THAT THERE WAS A KINK IN THE NEEDLE AT THE DISTAL END. A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER COMPLAINT COULD NOT BE DETERMINED, AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN A LABORATORY ENVIRONMENT, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. HOWEVER IT IS POSSIBLE THAT EXCESSIVE FORCE WAS APPLIED CAUSING THE NEEDLE TO KINK WHEN ATTACHING OR DETATCHING THE DEVICE TO THE SCOPE. DOCUMENTS REVIEW: THE ECHO-HD-3-20-C OF LOT NUMBER C1274102 DEVICE INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, WITH ORIGINAL PACKAGING. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT BASED INVESTIGATION WAS CONDUCTED. A REVIEW OF THE QC RECORDS DID NOT REVEAL ANY ISSUES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. PRIOR TO DISTRIBUTION, ALL ECHO-HD-3-20-C DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE (IFU0077-4 ). THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, IFU0077-4, WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER TO INSPECT THE DEVICE PRIOR TO USE FOR ANY DAMAGE: "VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE". A REVIEW OF THE MANUFACTURING RECORDS FOR ECHO-HD-3-20-C DEVICE OF LOT# C1274102 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS OCCURRENCE. THERE IS NO EVIDENCE TO SUGGEST THAT THIS ISSUE AFFECTS THE ENTIRE LOT # C1274102; UPON REVIEW OF COMPLAINTS THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT # C1274102. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS. SUMMARY THE CUSTOMER COMPLAINT IS CONSIDERED TO BE CONFIRMED BASED ON CUSTOMER TESTIMONY. THE RISK WAS DETERMINED TO BE RISK CATEGORY III/NO RISK LEVEL. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY SIDE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
AFTER PHYSICIAN DID EUS-FNB 1ST PUNCTURE, NURSE TRIED TO GET THE STYLET IN TO THE SHEATH. BUT SOMEWHERE IN THE MIDDLE, STYLET STUCK IN. DIDN'T MOVE FORWARD AT ALL. JUST THE NEEDLE OUT OF THE SCOPE CHANNEL AND BEING REMOVED. DURING THE LAB EVALUATION IT WAS NOTED THAT THE NEEDLE WAS KINKED DISTALLY.
AFTER PHYSICIAN DID EUS-FNB 1ST PUNCTURE, NURSE TRIED TO GET THE STYLET IN TO THE SHEATH. BUT SOMEWHERE IN THE MIDDLE, STYLET STUCK IN. DIDN'T MOVE FORWARD AT ALL. JUST THE NEEDLE OUT OF THE SCOPE CHANNEL AND BEING REMOVED. DURING THE LAB EVALUATION IT WAS NOTED THAT THE NEEDLE WAS KINKED DISTALLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 189043 | ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE | FCG KIT, NEEDLE, BIOPSY | FCG | COOK IRELAND LTD | G34785 | 00827002347854 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 0 DA |