ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE
Report
- Report Number
- 3001845648-2018-00204
- Event Type
- Injury
- Date Received
- May 2, 2018
- Date of Event
- April 6, 2018
- Report Date
- October 30, 2018
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FCG
- UDI-DI
- 00827002342798
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
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). (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). DEVICE EVALUATION: THE ECHO-HD-22-EBUS-P-C DEVICE OF LOT NUMBER C1448941 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 03 OCTOBER 2018. ON LABORATORY EVALUATION OF THE RETURNED DEVICE, KINK OBSERVED AT PROXIMAL END BELOW SHEATH ADJUSTER LIKELY DUE TO REPACKAGING FOR TRANSPORT RETURNS. NEEDLE DISTAL BREAK. SYRINGE AND NEEDLE TIP MISSING. STYLET DIFFICULT TO ADVANCE LIKELY DUE TO KINK. NEEDLE OUT OF SHEATH MEASURED AT 4.1 CM. (SPECIFICATION FOR NEEDLE 965MM +2MM/-2MM) STYLET DIFFICULT TO ADVANCE. FOLLOWING THE LABORATORY INFORMATION ADDITIONAL INFORMATION WAS REQUESTED TO CLARIFY IF THE BROKEN NEEDLE TIP WAS RETRIEVED FROM THE PATIENT. HOWEVER NO RESPONSE RECEIVED. THEREFORE, IF THIS INFORMATION BECOMES AVAILABLE THE INVESTIGATION WILL BE UPDATED ACCORDINGLY. 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, A POSSIBLE CAUSE FOR THIS ISSUE MAY HAVE BEEN THAT THE TARGETED LESION WAS HARD AS PER ADDITIONAL INFORMATION PROVIDED OR WHEN PASSING THROUGH TRACHEAL RING. THE CUSTOMER COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. 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¿. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE (IFU0110-5). DOCUMENT REVIEW: COMPONENTS SUPPLIED BY EXTERNAL SUPPLIERS ARE SUBJECT TO GOODS INWARDS QUALITY INSPECTION. A REVIEW OF GOODS INWARDS RECORDS FOUND THAT ALL RELEVANT PARTS WERE ACCEPTED INTO CIRL. 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. PRODUCT ASSEMBLY FINISHED PRODUCT QC INSTRUCTIONS INCLUDE, ¿MEASURE THE NEEDLE EXTENSION WITH THE OUTER HANDLE POSITIONED AT REFERENCE MARK 5 AND WITH THE SHEATH IN A STRAIGHT POSITION. THE NEEDLE EXTENSION SHOULD BE AS PER THE DRAWING AND FREE FROM ANY DAMAGE / KINKS.¿ ALL PRODUCTS AND PACKAGING ARE 100% INSPECTED FOR VISUAL IRREGULARITIES SUCH AS HOLES, DENTS, KINKS OR TEARS. AS PER PROCEDURE, "CHECK FOR DIMPLING ON NEEDLE." "MEASURE LENGTH OF DIMPLING." "MEASURE LENGTH FROM DISTAL END OF DIMPLING TO PROXIMAL END OF BEVEL. MEASURE THE LENGTH FROM THE NOTCH TO THE DIMPLING". A REVIEW OF THE MANUFACTURING RECORDS FOR ECHO-HD-22-EBUS-P-C OF LOT NUMBER C1448941 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THERE IS NO EVIDENCE TO SUGGEST THAT THIS ISSUE AFFECTS THE ENTIRE LOT # C1448941 UPON REVIEW OF COMPLAINTS THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT # C1448941. SUMMARY: THE CUSTOMER COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
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). THE DEVICE WAS RETURNED ON 02 OCT 18. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
AS REPORTED TO CUSTOMER RELATIONS, "THE TIP OF THE NEEDLE BROKE OFF INSIDE THE PATIENT DURING THE PROCEDURE AND WAS UNABLE TO BE RETRIEVED." ADDITIONAL INFO PROVIDED BY COOK CANADA: DURING EBUS PROCEDURE ATTEMPTS WERE MADE TO BIOPSY LYMPH NODE. DURING SECOND ATTEMPT IT WAS VERY DIFFICULT TO INSERT NEEDLE INTO NODE. AFTER WITHDRAWAL OF NEEDLE FROM SITE IT WAS NOTED ON CAMERA VIEW THAT THE NEEDLE TIP WAS BROKEN OFF INTO PATIENT AIRWAY. PROCEDURE WAS ABORTED AND BRONCHOSCOPE WAS INSERTED TO ATTEMPT RETRIEVAL OF THE NEEDLE TIP. NEEDLE TIP WAS NO LONGER VISIBLE AT THE SITE AND COULD NOT BE LOCATED. PATIENT WAS STABLE THROUGHOUT PROCEDURES. PATIENT WAS TAKEN TO RECOVERY. CHEST X-RAY WAS ORDERED. PATIENT WILL CONTINUE TO BE FOLLOWED UP AND WILL LATER HAVE ANOTHER PROCEDURE
AS REPORTED TO CUSTOMER RELATIONS, "THE TIP OF THE NEEDLE BROKE OFF INSIDE THE PATIENT DURING THE PROCEDURE AND WAS UNABLE TO BE RETRIEVED." ADDITIONAL INFO PROVIDED BY COOK CANADA: DURING EBUS PROCEDURE ATTEMPTS WERE MADE TO BIOPSY LYMPH NODE. DURING SECOND ATTEMPT IT WAS VERY DIFFICULT TO INSERT NEEDLE INTO NODE. AFTER WITHDRAWAL OF NEEDLE FROM SITE IT WAS NOTED ON CAMERA VIEW THAT THE NEEDLE TIP WAS BROKEN OFF INTO PATIENT AIRWAY. PROCEDURE WAS ABORTED AND BRONCHOSCOPE WAS INSERTED TO ATTEMPT RETRIEVAL OF THE NEEDLE TIP. NEEDLE TIP WAS NO LONGER VISIBLE AT THE SITE AND COULD NOT BE LOCATED. PATIENT WAS STABLE THROUGHOUT PROCEDURES. PATIENT WAS TAKEN TO RECOVERY. CHEST X-RAY WAS ORDERED. PATIENT WILL CONTINUE TO BE FOLLOWED UP AND WILL LATER HAVE ANOTHER PROCEDURE
AS REPORTED TO CUSTOMER RELATIONS, "THE TIP OF THE NEEDLE BROKE OFF INSIDE THE PATIENT DURING THE PROCEDURE AND WAS UNABLE TO BE RETRIEVED." ADDITIONAL INFO PROVIDED BY COOK (B)(4): DURING EBUS PROCEDURE ATTEMPTS WERE MADE TO BIOPSY LYMPH NODE. DURING SECOND ATTEMPT IT WAS VERY DIFFICULT TO INSERT NEEDLE INTO NODE. AFTER WITHDRAWAL OF NEEDLE FROM SITE IT WAS NOTED ON CAMERA VIEW THAT THE NEEDLE TIP WAS BROKEN OFF INTO PATIENT AIRWAY. PROCEDURE WAS ABORTED AND BRONCHOSCOPE WAS INSERTED TO ATTEMPT RETRIEVAL OF THE NEEDLE TIP. NEEDLE TIP WAS NO LONGER VISIBLE AT THE SITE AND COULD NOT BE LOCATED. PATIENT WAS STABLE THROUGHOUT PROCEDURES. PATIENT WAS TAKEN TO RECOVERY. CHEST X-RAY WAS ORDERED. PATIENT WILL CONTINUE TO BE FOLLOWED UP AND WILL LATER HAVE ANOTHER PROCEDURE.
THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE EVALUATION OF THE RETURNED DEVICE. AS REPORTED TO CUSTOMER RELATIONS, "THE TIP OF THE NEEDLE BROKE OFF INSIDE THE PATIENT DURING THE PROCEDURE AND WAS UNABLE TO BE RETRIEVED." ADDITIONAL INFO PROVIDED BY COOK CANADA: DURING EBUS PROCEDURE ATTEMPTS WERE MADE TO BIOPSY LYMPH NODE. DURING SECOND ATTEMPT IT WAS VERY DIFFICULT TO INSERT NEEDLE INTO NODE. AFTER WITHDRAWAL OF NEEDLE FROM SITE IT WAS NOTED ON CAMERA VIEW THAT THE NEEDLE TIP WAS BROKEN OFF INTO PATIENT AIRWAY. PROCEDURE WAS ABORTED AND BRONCHOSCOPE WAS INSERTED TO ATTEMPT RETRIEVAL OF THE NEEDLE TIP. NEEDLE TIP WAS NO LONGER VISIBLE AT THE SITE AND COULD NOT BE LOCATED. PATIENT WAS STABLE THROUGHOUT PROCEDURES. PATIENT WAS TAKEN TO RECOVERY. CHEST X-RAY WAS ORDERED. PATIENT WILL CONTINUE TO BE FOLLOWED UP AND WILL LATER HAVE ANOTHER PROCEDURE
510(K) NUMBER: K160229. (B)(4). EXEMPTION NUMBER: E2016031. (B)(4). THE ECHO-HD-22-EBUS-P-C DEVICE OF LOT NUMBER C1448941 INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. ADDITIONAL INFORMATION WAS RECEIVED AS FOLLOWS: DID THE BROKEN NEEDLE FALL INTO THE PATIENT? - YES. IF SO HOW WAS IT RETRIEVED? - IT WAS UNABLE TO BE RETRIEVED. IF THE REPORT INVOLVES A KINK OR BEND IN THE NEEDLE, WHERE IS THIS LOCATED ON THE DEVICE (HANDLE END OR PATIENT END)? NO PLEASE DESCRIBE THE LOCATION IN THE BODY FOR THE INTENDED TARGET SITE (PANCREAS, STOMACH, ETC.). LUNG PROXIMAL LLL PLEASE DESCRIBE THE SIZE OF THE INTENDED TARGET SITE. NOT DOCUMENTED IN PROCEDURE REPORT WHAT IS THE ENDOSCOPE MANUFACTURER AND MODEL NUMBER THAT WAS USED WITH THIS DEVICE? PENTAX EB-1970UK. WAS GAINING ACCESS TO THE TARGETED SITE DIFFICULT? NO. WAS THE ENDOSCOPE IN A FLEXED OR TWISTED POSITION AT ANY TIME DURING THE PROCEDURE? NO. WAS NEEDLE PENETRATION OF THE TARGETED SITE DIFFICULT? YES. WAS THE STYLET IN PLACE INSIDE THE NEEDLE WHEN ADVANCING INTO THE TARGETED SITE? YES. HOW MANY BIOPSIES WERE OBTAINED WITH USE OF THIS NEEDLE?1 (BROKE ON THE SECOND PASS). DID ANY SECTION OF THE DEVICE DETACH INSIDE THE PATIENT? YES (IT WAS VISUALIZED ON THE SCREEN WHEN THE NEEDLE WAS REMOVED FROM THE TARGET SITE). WAS THE NEEDLE FULLY RETRACTED WHEN THE DEVICE WAS REMOVED FROM THE PATIENT? YES (WHAT WAS NOT BROKEN OFF). IF NOT, WITH THE DEVICE IN QUESTION, HOW WAS THE PROCEDURE PERFORMED AND/OR FINISHED? PROCEDURE ABORTED AFTER BREAKAGE OF DEVICE AND ATTEMPTS WERE MADE WITH A BRONCHOSCOPE TO LOCATE AND RETRIEVE THE DEVICE BUT IT WAS UNABLE TO BE LOCATED. THE NURSE MANAGER FROM (B)(6) GENERAL HAS ADVISED ME THAT SHE CANNOT NO LONGER DISCUSS THE EBUS NEEDLE CASE WITH ME UNTIL REGULATORY HAS FINISHED ITS INVESTIGATION. I ASKED HER IF SHE COULD RESPOND TO THE COUPLE OF QUESTIONS AND AGAIN SHE RESPONDED WITH THIS: ¿I HAVE BEEN INSTRUCTED TO WAIT FOR OUR PATIENT SAFETY DEPARTMENT TO GIVE ME THE GO AHEAD BEFORE ANSWERING THE QUESTIONS FOR YOUR REGULATORY.¿ DEFINITIVE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, A POSSIBLE CAUSE FOR THIS ISSUE MAY HAVE BEEN THAT THE TARGETED LESION WAS HARD AS PER ADDITIONAL INFORMATION PROVIDED OR WHEN PASSING THROUGH TRACHEAL RING THE CUSTOMER COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY, AS DEVICE WAS NOT RETURNED. 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¿. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE (IFU0110-5). DOCUMENT 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 COOK (B)(4). A REVIEW OF THE MANUFACTURING RECORDS FOR ECHO-HD-22-EBUS-P-C OF LOT NUMBER C1448941 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THERE IS NO EVIDENCE TO SUGGEST THAT THIS ISSUE AFFECTS THE ENTIRE LOT # C1448941 UPON REVIEW OF COMPLAINTS THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT # C1448941. SUMMARY: THE CUSTOMER COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY, AS DEVICE WAS NOT RETURNED. THE RISK WAS DETERMINED TO BE IIB CATEGORY /MODERATE RISK LEVEL. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
AS REPORTED TO CUSTOMER RELATIONS, "THE TIP OF THE NEEDLE BROKE OFF INSIDE THE PATIENT DURING THE PROCEDURE AND WAS UNABLE TO BE RETRIEVED." ADDITIONAL INFO PROVIDED BY COOK (B)(4): DURING EBUS PROCEDURE ATTEMPTS WERE MADE TO BIOPSY LYMPH NODE. DURING SECOND ATTEMPT IT WAS VERY DIFFICULT TO INSERT NEEDLE INTO NODE. AFTER WITHDRAWAL OF NEEDLE FROM SITE IT WAS NOTED ON CAMERA VIEW THAT THE NEEDLE TIP WAS BROKEN OFF INTO PATIENT AIRWAY. PROCEDURE WAS ABORTED AND BRONCHOSCOPE WAS INSERTED TO ATTEMPT RETRIEVAL OF THE NEEDLE TIP. NEEDLE TIP WAS NO LONGER VISIBLE AT THE SITE AND COULD NOT BE LOCATED. PATIENT WAS STABLE THROUGHOUT PROCEDURES. PATIENT WAS TAKEN TO RECOVERY. CHEST X-RAY WAS ORDERED. PATIENT WILL CONTINUE TO BE FOLLOWED UP AND WILL LATER HAVE ANOTHER PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 322586 | ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE | FCG KIT, NEEDLE, BIOPSY | FCG | COOK IRELAND LTD | G34279 | C1448941 | 00827002342798 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |