ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE
Report
- Report Number
- 3001845648-2019-00046
- Event Type
- Injury
- Date Received
- February 14, 2019
- Date of Event
- January 15, 2019
- Report Date
- April 8, 2019
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FCG
- UDI-DI
- 00827002347854
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
PMA/510(K) # K142688. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. IMPORTER SITE CONTACT AND ADDRESS: (B)(6). 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) # 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)(6). 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) # 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)(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 EVALUATION OF THE DEVICE INVOLVED IN THIS EVENT AND THE CONCLUSION OF THIS INVESTIGATION. INVESTIGATION DETAILS: THE ECHO-HD-3-20-C DEVICE OF LOT NUMBER C1548703 INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, WITHOUT THE 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 THE 13 FEB 2019. THERE WAS A BREAK AT THE DISTAL TIP OF THE NEEDLE. THERE WAS ANOTHER BREAK PROXIMAL TO THE SHEATH EXTENDER, WHICH WAS RELATED TO THE DISTAL TIP NEEDLE BREAK. 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. A REVIEW OF THE MANUFACTURING RECORDS FOR ECHO-HD-3-20-C OF LOT NUMBER C1548703 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 C1548703. THE NOTES SECTION OF THE INSTRUCTIONS FOR USE 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. THE FAILURE OF NEEDLE BREAK 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 FLEXED POSITION. COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. DISTAL TIP OF NEEDLE BREAK AND PROXIMAL TO SHEATH EXTENDER BREAK. 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) # 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.
NEEDLE BROKE INSIDE PANCREAS OF THE PATIENT .NEEDLE TIP IS STILL REMAINING INSIDE PANCREAS PATIENT. FOR THE MOMENT PATIENT IS OK. AS PER COMPLETE CUSTOMER COMPLAINT FORM: "DOCTOR WAS MAKING A PUNCTION IN PANCREAS HEAD AND HE RETRIEVED THE NEEDLE FROM SCOPE. HE RELEASED THAT NEEDLE WAS BROKEN AND THE NEEDLE TIP IS INSIDE THE PATIENT PANCREAS."
NEEDLE BROKE INSIDE PANCREAS OF THE PATIENT .NEEDLE TIP IS STILL REMAINING INSIDE PANCREAS PATIENT. FOR THE MOMENT PATIENT IS OK. AS PER COMPLETE CUSTOMER COMPLAINT FORM: "DOCTOR WAS MAKING A PUNCTION IN PANCREAS HEAD AND HE RETRIEVED THE NEEDLE FROM SCOPE. HE RELEASED THAT NEEDLE WAS BROKEN AND THE NEEDLE TIP IS INSIDE THE PATIENT PANCREAS."
THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE EVALUATION OF THE DEVICE INVOLVED IN THIS EVENT AND THE CONCLUSION OF THIS INVESTIGATION. INITIAL REPORT DETAILS: NEEDLE BROKE INSIDE PANCREAS OF THE PATIENT .NEEDLE TIP IS STILL REMAINING INSIDE PANCREAS PATIENT. FOR THE MOMENT PATIENT IS OK. AS PER COMPLETE CUSTOMER COMPLAINT FORM: "DOCTOR WAS MAKING A PUNCTION IN PANCREAS HEAD AND HE RETRIEVED THE NEEDLE FROM SCOPE. HE RELEASED THAT NEEDLE WAS BROKEN AND THE NEEDLE TIP IS INSIDE THE PATIENT PANCREAS."
NEEDLE BROKE INSIDE PANCREAS OF THE PATIENT. NEEDLE TIP IS STILL REMAINING INSIDE PANCREAS PATIENT. FOR THE MOMENT PATIENT IS OK. AS PER COMPLETE CUSTOMER COMPLAINT FORM: "DOCTOR WAS MAKING A PUNCTION IN PANCREAS HEAD AND HE RETRIEVED THE NEEDLE FROM SCOPE. HE RELEASED THAT NEEDLE WAS BROKEN AND THE NEEDLE TIP IS INSIDE THE PATIENT PANCREAS."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 133872 | ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE | FCG KIT, NEEDLE, BIOPSY | FCG | COOK IRELAND LTD | G34785 | C1548703 | 00827002347854 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |