ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE
Report
- Report Number
- 3001845648-2019-00105
- Event Type
- Malfunction
- Date Received
- March 14, 2019
- Date of Event
- February 13, 2019
- Report Date
- May 9, 2019
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FCG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
(B)(4). 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: ED SUTKOWSKI, COOK MEDICAL INCORPORATED (CMI), 1025 ACUFF ROAD, P.O BOX 4195, BLOOMINGTON , INDIANA , 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
PMA/510(K) #K160229. 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.
PMA/510(K) #K160229. 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. THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION AND CONCLUSIONS INTO THIS EVENT . COMPLAINT DEVICE WAS NOT RETURNED THEREFORE A DOCUMENT BASED REVIEW WILL BE PERFORMED. CLARIFICATION WAS REQUESTED IF THE NEEDLE BENT AND/OR BROKE. IT WAS CONFIRMED THAT THE NEEDLE DID NOT BREAK BUT WAS JUST BENT. CLARIFICATION WAS ALSO REQUESTED AS TO HOW THE PROCEDURE WAS COMPLETED. IT WAS CONFIRMED THAT IT WAS COMPLETED WITH ANOTHER NEEDLE. PRIOR TO DISTRIBUTION, ALL ECHO-HD-22-EBUS-P 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. A REVIEW OF THE MANUFACTURING RECORDS FOR ECHO-HD-22-EBUS-P OF LOT NUMBER C1570631 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE REVIEW OF RELEVANT MANUFACTURING RECORDS, 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 C1570631. THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, 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" AND "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 IN RELATION TO USE OF THE STYLET. THE FAILURE OF NEEDLE KINKED/BENT WAS CONCLUDED FROM THE AVAILABLE INFORMATION. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE 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 WHICH COULD HAVE LED TO THE NEEDLE BEND AFTER THE 1ST PASS. COMPLAINT IS CONFIRMED BASED ON THE CUSTOMERS TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
PMA/510(K) #K160229. 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). INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
A PART OF THE NEEDLE WAS BROKEN IN 3 CASES. AS PER COMPETED COMPLAINT FORM:" A PART OF THE NEEDLE IT WAS BREAK IN 3 CASES." AS PER UPDATED CUSTOMER COMPLAINT FORM: "LOT.:C1570631 BEND AT 45º THE LOT.: C1553481 BREAK. THIS REPORT INVESTIGATES THE NEEDLE BEND. REFERENCE ALSO REPORT# 3001845648-2019-00101.
A PART OF THE NEEDLE WAS BROKEN IN 3 CASES. REP HAS INDICATED "IT IS 2 PATIENTS AND TWO PROCEDURES IN 'DEFENCE' DAYS." ADDITIONAL INFORMATION REQUESTED. NO FURTHER INFORMATION PROVIDED TO DATE. CONFLICTING COMPLAINT DESCRIPTION HAS BEEN RECEIVED AND CLARIFICATIONS HAVE BEEN REQUESTED.
A PART OF THE NEEDLE WAS BROKEN IN 3 CASES. AS PER COMPETED COMPLAINT FORM:" A PART OF THE NEEDLE IT WAS BREAK IN 3 CASES." AS PER UPDATED CUSTOMER COMPLAINT FORM: "LOT.:C1570631 BEND AT 45º THE LOT.: C1553481 BREAK. THIS REPORT INVESTIGATES THE NEEDLE BEND. REFERENCE ALSO REPORT# 3001845648-2019-00101.
A PART OF THE NEEDLE WAS BROKEN IN 3 CASES. AS PER COMPETED COMPLAINT FORM:" A PART OF THE NEEDLE IT WAS BREAK IN 3 CASES." AS PER UPDATED CUSTOMER COMPLAINT FORM: "LOT.:C1570631 BEND AT 45º THE LOT.: C1553481 BREAK. THIS REPORT INVESTIGATES THE NEEDLE BEND. REFERENCE ALSO REPORT# 3001845648-2019-00101.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 214434 | ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE | FCG KIT, NEEDLE, BIOPSY | FCG | COOK IRELAND LTD | C1570631 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |