ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE
Report
- Report Number
- 3001845648-2019-00706
- Event Type
- Malfunction
- Date Received
- December 11, 2019
- Report Date
- January 8, 2020
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FCG
- UDI-DI
- 00827002347854
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
PMA/510(K) #K142688. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
PMA/510(K) #K142688. THE ECHO-HD-3-20-C DEVICE OF LOT NUMBER C1609367, INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, WITH THE ORIGINAL PACKAGING. THE PACKAGING WAS OPEN ON RECEIPT. 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 . A PROXIMAL BREAK WAS NOTED AT APPROXIMATELY 33.7CM FROM BOTTOM OF HUB(BELOW SHEATH EXTENDER). 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 RELEVANT MANUFACTURING RECORDS (C1609367) REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. UPON REVIEW OF COMPLAINTS, THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS 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 C1609367. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR 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." A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN THE LABORATORY. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO TORTUOUS ANATOMY REQUIRING TWISTED ENDOSCOPE POSITION AS INDICATED IN THE ADDITIONAL INFORMATION. COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. 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.
DURING AN ENDO SOUND WITH THE PUNCTURE NEEDLE, THE NEEDLE SUDDENLY CAME OFF THE HANDLE AND STUCK IN THE DEVICE. AS PER COMPLAINT FORM: "WHEN THE NEEDLE WAS RETRACTED, THE NEEDLE DETACHED FROM THE HANDLE AND COULD NOT BE PULLED BACK INTO THE TUBE VIA THE HANDLE.". NEEDLE IS COMPLETELY TORN OFF THE HANDLE. PUNCTURE PANCREATIC HEAD.
DURING AN ENDO SOUND WITH THE PUNCTURE NEEDLE, THE NEEDLE SUDDENLY CAME OFF THE HANDLE AND STUCK IN THE DEVICE. AS PER COMPLAINT FORM: "WHEN THE NEEDLE WAS RETRACTED, THE NEEDLE DETACHED FROM THE HANDLE AND COULD NOT BE PULLED BACK INTO THE TUBE VIA THE HANDLE." NEEDLE IS COMPLETELY TORN OFF THE HANDLE. PUNCTURE PANCREATIC HEAD.
PMA/510(K) #: K142688. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
DURING AN ENDO SOUND WITH THE PUNCTURE NEEDLE, THE NEEDLE SUDDENLY CAME OFF THE HANDLE AND STUCK IN THE DEVICE. AS PER COMPLAINT FORM: "WHEN THE NEEDLE WAS RETRACTED, THE NEEDLE DETACHED FROM THE HANDLE AND COULD NOT BE PULLED BACK INTO THE TUBE VIA THE HANDLE." NEEDLE IS COMPLETELY TORN OFF THE HANDLE. PUNCTURE PANCREATIC HEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1247223 | ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE | FCG KIT, NEEDLE, BIOPSY | FCG | COOK IRELAND LTD | G34785 | C1609367 | 00827002347854 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |