ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE
Report
- Report Number
- 3001845648-2022-00381
- Event Type
- Injury
- Date Received
- June 23, 2022
- Date of Event
- May 19, 2022
- Report Date
- November 22, 2022
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FCG
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- 003
Narratives
PMA/510(K) # K210476. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
PMA/510(K) # K210476 DEVICE EVALUATION (B)(4) UNIT OF LOT C1857521 OF ECHO-HD-3-20-C WAS RETURNED OPENED NOT IN ITS ORIGINAL PACKAGING. LAB EVALUATION THE DEVICE INVOLVED IN THIS COMPLAINT WAS EVALUATED IN THE LABORATORY ON 11 JULY 2022. THE RETURNED DEVICE LAB FINDINGS AND OBSERVATIONS CAN BE REFERRED THROUGH THE ATTACHED FILES. THE DISTAL END OF THE NEEDLE WAS OBSERVED TO BE BROKEN. DURING THE LAB EVALUATION OF (B)(4) A PROXIMAL KINK WAS NOTED AS AN ADDITIONAL FAILURE. DOCUMENT REVIEW INCLUDING IFU REVIEW 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 C1857521 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 C1857521. 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 N/A ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER COMPLAINT COULD NOT BE DETERMINED AS CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN THE LABORATORY. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO A DIFFICULT TARGET SITE, IT IS POSSIBLE THE ACTUAL LESION WAS HARD LEADING TO THE DISTAL END OF THE NEEDLE TO BREAK. SUMMARY COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
PMA/510(K) # K210476. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
USER DETECTED THE NEEDLE TIP BROKEN IN PATIENT TARGET AREA(MEDIASTINAL LYMPH NODES OUTSIDE THE ESOPHAGEAL WALL) DURING FOURTH BIOPSY ATTEMPT. THE NEEDLE TIP REMAINS IN PATIENT.
SUPPLEMENTAL FOLLOW-UP REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION AND AN UPDATE TO THE INVESTIGATION CONCLUSIONS ON THE 22-NOV-2022.
THIS FOLLOW UP MDR IS BEING SUBMITTED TO CAPTURE THE LAB EVALUATION: COMPLAINT DEVICE WAS RETURNED AND EVALUATED ON 11-JUL-2022: VISUAL INSPECTION: DISTAL END OF NEEDLE EXAMINED AND DISTAL BREAK OBSERVED APPROXIMATELY 6.5CM FROM TIP OF SHEATH. DEVICE EXAMINED AND PROXIMAL KINK BELOW THE SHEATH EXTENDER OBSERVED. FUNCTIONAL INSPECTION: SHEATH EXTENDER ABLE TO RETRACT FULLY BUT UNABLE TO PASS PROXIMAL KINK BELOW THE SHEATH EXTENDER. NEEDLE ABLE TO ADVANCE AND RETRACT WITH NO ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 264851 | ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE | FCG KIT, NEEDLE, BIOPSY | FCG | COOK IRELAND LTD | C1857521 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Female | Required Intervention |