ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE
Report
- Report Number
- 3001845648-2018-00079
- Event Type
- Malfunction
- Date Received
- February 22, 2018
- Date of Event
- January 26, 2018
- Report Date
- February 22, 2018
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FCG
- UDI-DI
- 00827002342798
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DE, US
- Reporter Occupation
- OTHER
Narratives
510(K) NUMBER: 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.
510(K) NUMBER: 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) (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). THIS FOLLOW UP VIGILANCE REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT. IN LINE WITH ISO14971: 2012, UPDATES WERE MADE TO CIRLS RISK MANAGEMENT SYSTEM IN NOVEMBER 2017. THESE UPDATES INCLUDED THE REQUIREMENT TO IDENTIFY THE INITIAL PROBABILITY OF OCCURRENCE AND THE INDIVIDUAL RISK LEVELS ASSOCIATED WITH EACH HAZARD AND HAZARDOUS SITUATION. AS A RESULT OF THE SYSTEM UPDATES THE RISK DOCUMENTATION HAS BEEN REVISED. THE SEVERITY ASSOCIATED WITH THE HAZARDOUS SITUATION HAS NOT CHANGED HOWEVER THE IDENTIFIED RISK LEVELS ASSOCIATED WITH KINKS OR BREAKS WITHIN THE HANDLE AND BELOW THE SHEATH EXTENSION ON ECHO EBUS DEVICES HAVE REDUCED, AND ARE NOW IDENTIFIED AS PRESENTING A LOW RISK TO THE PATIENT OR END-USER. THIS EVENT HAS BEEN RE-ASSESSED AND THIS REPORT IS TO NOTIFY THE FDA THAT THIS EVENT NO LONGER MEETS THE FDA REPORTING CRITERIA OF A MALFUNCTION REPORT. NO ADVERSE EFFECTS TO THE PATIENT WAS REPORTED AS OCCURRING.
510(K) NUMBER: K160229. (B)(4). EXEMPTION NUMBER: E2016031. (B)(4). ADDITIONAL INFORMATION 01 FEB 2018; "THIS COMPLAINT WAS NOT ABOUT KINKING OF THE WIRE (STYLET) BUT BECAUSE OF NEELE TIP KINKING." LAB EVALUATION: 3 X ECHO-HD-EBUS-P-C DEVICES OF LOT #C1425549 WERE RETURNED TO CIRL FOR EVALUATION. UPON EVALUATION, 3 DEVICES WERE RETURNED. DEVICE 1 HAD THE STYLET FULLY IN PLACE AND HAD NO NEEDLE EXPOSURE. THE NEEDLE ADVANCED AND RETRACTED WITHOUT ISSUE. THE STYLET WAS VERY ACCESSIBLE AND THERE WAS A SLIGHT BEND BELOW THE SHEATH EXTENDER. DEVICE 2 HAD ITS STYLET PARTIALLY OUT UPON RETURN AND THERE WAS NO NEEDLE EXPOSURE. THE STYLET WAS VERY STIFF AND THE NEEDLE TIP WAS INTACT. THERE WAS A BEND BELOW THE SHEATH EXTENDER. THE DEVICE WAS DISMANTLED AND A KINK WAS PRESENT BELOW THE SHEATH EXTENDER. DEVICE 3 HAD THE STYLET FULLY IN PLACE AND HAD NO NEEDLE EXPOSURE. THE NEEDLE ADVANCED AND RETRACTED WITHOUT ISSUE. THE STYLET WAS VERY ACCESSIBLE AND THERE WAS A SLIGHT BEND BELOW THE SHEATH EXTENDER. ROOT CAUSE: A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER COMPLAINT COULD NOT BE DETERMINED AS THE EXACT OPERATIONAL CONDITIONS OF USE COULD NOT BE REPLICATED IN THE LABORATORY SETTING. HOWEVER IT IS POSSIBLE THAT THE USER MAY HAVE EXERTED EXCESSIVE FORCE WHILST ATTACHING AND DETACHING THE DEVICE FROM THE SCOPE CAUSING THE NEEDLE TO BEND BELOW THE SHEATH EXTENDER. THIS WOULD ACCOUNT FOR THE STYLET DIFFICULTIES ENCOUNTERED BY THE USER WITH DEVICE 2 AS IT WOULD NOT BE ABLE TO PASS THE BEND IN THE NEEDLE. THIS COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. DOCUMENTS REVIEW: PRIOR TO DISTRIBUTION, ALL ECHO-HD-22-EBUS-P-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. IFU REVIEW: IT MAY BE NOTED THAT ACCORDING TO THE INSTRUCTIONS FOR USE, IFU0110-5, THE USER IS INSTRUCTED TO: ¿VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF ANY ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE¿. A REVIEW OF THE MANUFACTURING RECORDS FOR ECHO-HD-22-EBUS-P-C OF LOT NUMBER C1425549 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. A REVIEW OF THE INFORMATION PROVIDED, INDICATES THE IFU HAS BEEN FOLLOWED. THERE IS NO EVIDENCE TO SUGGEST THAT THIS ISSUE AFFECTS THE ENTIRE LOT # C1425549 UPON REVIEW OF COMPLAINTS THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT # C1425549. SUMMARY: FROM THE INFORMATION PROVIDED, NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS A RESULT OF THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
"AS PER COMPLAINT FORM": AFTER THE FIRST AND THE SECOND PUNCTURE WITH THE SAME NEEDLE, THE CUSTOMER COULD NOT INTRODUCE THE WIRE (THE PART WHICH IS INSIDE THE NEEDLE) ANYMORE BECAUSE IT KINKED.
THIS FOLLOW UP REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT. IN LINE WITH (B)(4): 2012, UPDATES WERE MADE TO CIRLS RISK MANAGEMENT SYSTEM IN NOVEMBER 2017. THESE UPDATES INCLUDED THE REQUIREMENT TO IDENTIFY THE INITIAL PROBABILITY OF OCCURRENCE AND THE INDIVIDUAL RISK LEVELS ASSOCIATED WITH EACH HAZARD AND HAZARDOUS SITUATION. AS A RESULT OF THE SYSTEM UPDATES THE RISK DOCUMENTATION HAS BEEN REVISED. THE SEVERITY ASSOCIATED WITH THE HAZARDOUS SITUATION HAS NOT CHANGED HOWEVER THE IDENTIFIED RISK LEVELS ASSOCIATED WITH KINKS OR BREAKS WITHIN THE HANDLE AND BELOW THE SHEATH EXTENSION ON ECHO EBUS DEVICES HAVE REDUCED, AND ARE NOW IDENTIFIED AS PRESENTING A LOW RISK TO THE PATIENT OR END-USER. WIRE GUIDE IS BENT. "AS PER COMPLAINT FORM":AFTER THE FIRST AND THE SECOND PUNCTURE WITH THE SAME NEEDLE, THE CUSTOMER COULD NOT INTRODUCE THE WIRE (THE PART WHICH IS INSIDE THE NEEDLE) ANYMORE BECAUSE IT KINKED.
WIRE GUIDE IS BENT. "AS PER COMPLAINT FORM": AFTER THE FIRST AND THE SECOND PUNCTURE WITH THE SAME NEEDLE, THE CUSTOMER COULD NOT INTRODUCE THE WIRE (THE PART WHICH IS INSIDE THE NEEDLE) ANYMORE BECAUSE IT KINKED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 134224 | ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE | FCG KIT, NEEDLE, BIOPSY | FCG | COOK IRELAND LTD | G34279 | 00827002342798 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |