ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE
Report
- Report Number
- 3001845648-2024-00159
- Event Type
- Malfunction
- Date Received
- April 9, 2024
- Date of Event
- September 13, 2017
- Report Date
- September 5, 2024
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FCG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
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. SUPPLEMENTAL CORRECTION REPORT IS BEING SUBMITTED FOLLOWING A REVIEW OF THIS COMPLAINT FILE. RPN IS BEING UPDATED. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
PMA/510(K) # K210476. DEVICE EVALUATION: THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE FILE WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE, "COMPARISON OF THE DIAGNOSTIC YIELD OF EUS NEEDLES FOR LIVER BIOPSY: EX VIVO STUDY." MANUFACTURING RECORDS: PRIOR TO DISTRIBUTION, ALL ECHO-HD-19-C DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. REVIEW HISTORICAL DATA: HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. INSTRUCTIONS FOR USE AND LABEL: AS PER THE INSTRUCTIONS FOR USE, (IFU0077) WHICH INFORMS THE USER ABOUT THE PRECAUTIONS "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. (IFU0077) IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS: A DEFINITIVE 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. AS PER THE INFORMATION REPORTED IN THE PAPER, NO STYLET WAS USED IN THE PROCEDURE WITH THE ECHO PROCORE NEEDLE WHICH CONTRAVENES THE PRECAUTIONS SECTION OF THE INSTRUCTIONS FOR USE. CONFIRMATION OF COMPLAINT: COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. CORRECTIVE ACTION/CORRECTION: COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS. SUMMARY OF INVESTIGATION: ACCORDING TO THE CUSTOMER, LEE 2017 ¿ USER ERROR. CONFIRMED QUANTITY OF 1 DEVICE, CONFIRMED USED. ACCORDING TO THE INITIAL REPORT, THERE WAS NO PATIENT INVOLVEMENT. INVESTIGATION FINDINGS CONCLUDE THAT A DEFINITIVE 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. AS PER THE INFORMATION REPORTED IN THE PAPER, NO STYLET WAS USED IN THE PROCEDURE WITH THE ECHO PROCORE NEEDLE WHICH CONTRAVENES THE PRECAUTIONS SECTION OF THE INSTRUCTIONS FOR USE.
LEE 2017 - COMPARISON OF THE DIAGNOSTIC YIELD OF EUS NEEDLES FOR LIVER BIOPSY: EX VIVO STUDY TWO HUMAN UNEMBALMED CADAVER LIVERS WERE OBTAINED FROM THE UNIVERSITY OF MARYLAND ANATOMY BOARD.THESE LIVERS WERE FLUSHED AND PROCURED LESS THAN 24 HRS POST MORTEM AND DID NOT HARBOR CHRONIC LIVER DISEASE. FOUR COMMERCIALLY AVAILABLE 19-GAUGE EUS NEEDLES WERE UTILIZED TO PERFORM BIOPSY: COOK ECHOTIP PROCORE, OLYMPUS EZ SHOT 2, BOSTON SCIENTIFIC EXPECT SLIMLINE, AND COVIDIEN SHARK- CORE (FIGURE 1). AN 18-GAUGE PERCUTANEOUS NEEDLE (TRUCORE, ARGON MEDICAL DEVICES) WAS USED FOR COMPARISON. EACH NEEDLE WAS ANGLED PERPENDICULAR TO THE LIVER AND ADVANCED APPROXIMATELY 6 CM IN DEPTH. NO STYLETS WERE USED AND FULL SUCTION WAS APPLIED FOR EACH FNA NEEDLE. USER ERROR: NO STYLETS WERE USED AND FULL SUCTION WAS APPLIED FOR EACH FNA NEEDLE AS PER IFU0077 STYLET SHOULD BE FULLY INSERTED WHEN ADVANCING THE NEEDLE INTO THE BIOPSY SITE NOTE THIS PROCEDURE WAS PREFORMED ON CADAVER LIVERS.
SUPPLEMENTAL CORRECTION REPORT IS BEING SUBMITTED FOLLOWING A REVIEW OF THIS COMPLAINT FILE. RPN IS BEING UPDATED.
A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 05-SEP-2024.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2424758 | ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE | FCG KIT, NEEDLE, BIOPSY | FCG | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |