ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE
Report
- Report Number
- 3001845648-2019-00101
- Event Type
- Malfunction
- Date Received
- March 14, 2019
- Date of Event
- February 13, 2019
- Report Date
- April 11, 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
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 (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.
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)(6). COOK MEDICAL INCORPORATED (CMI), 1025 ACUFF ROAD, P.O BOX 4195, BLOOMINGTON, INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION INTO THIS EVENT. COMPLAINT DEVICE WAS NOT RETURNED THEREFORE A DOCUMENT BASED REVIEW WILL BE PERFORMED. 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 C1553481 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 C1553481. 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 BROKEN 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. CLARIFICATION WAS REQUESTED AS TO THE LENGTH OF THE BROKEN NEEDLE PART AND IF IT WAS KNOWN HOW THE NEEDLE PART WAS REMOVED FROM THE PATIENT. IT WAS CONFIRMED THAT THE NEEDLE PART WAS LESS THAN 1CM BUT WAS UNKNOWN WHERE THE NEEDLE PART WAS, ONLY THAT THE CT SCAN SHOWED IT WAS NOT PRESENT IN THE PATIENT. COMPLAINT IS CONFIRMED BASED ON THE CUSTOMER'S TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. A CT SCAN CONFIRMED NO NEEDLE PART INSIDE THE PATIENT. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
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 BREAKAGE. REFERENCE ALSO REPORT# 3001845648-2019-00105.
THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION INTO THIS EVENT. INITIAL REPORT DETAILS: 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 BREAKAGE. REFERENCE ALSO REPORT# 3001845648-2019-00105.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 215839 | ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE | FCG KIT, NEEDLE, BIOPSY | FCG | COOK IRELAND LTD | C1553481 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |