ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE
Report
- Report Number
- 3001845648-2018-00371
- Event Type
- Injury
- Date Received
- August 8, 2018
- Report Date
- November 23, 2020
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- PMA / PMN Number
- K083330
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
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 REPORT WILL BE SUBMITTED WITH THE INVESTIGATION CONCLUSIONS.
510(K) NUMBER: K083330 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: ED SUTKOWSKI COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195 IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113 DEVICE EVALUATION THE ECHO-19 DEVICE OF UNKNOWN LOT NUMBER 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. ADDITIONAL INFORMATION WAS RECEIVED AS FOLLOWS: 1. IF THE REPORT INVOLVES A KINK OR BEND IN THE NEEDLE, WHERE IS THIS LOCATED ON THE DEVICE (HANDLE END (PROXIMAL END) OR PATIENT END (DISTAL END))? DISTAL END 2. PLEASE DESCRIBE THE LOCATION IN THE BODY FOR THE INTENDED TARGET SITE (PANCREAS, STOMACH, LUNGS ETC.). EXCLUDED STOMACH (FROM SCOPE IN GASTRIC POUCH) A. IF THE LUNGS, WHICH LYMPH NODE WAS BEING TARGETED? E.G. 2R, 2L, 4R, AO, AR, 11RI, 11S ETC. N/A 3. PLEASE DESCRIBE THE SIZE OF THE INTENDED TARGET SITE. EXCLUDED STOMACH (THICK WALL) 4. IF NOT WITH THE DEVICE IN QUESTION, HOW WAS THE PROCEDURE PERFORMED AND/OR FINISHED? RETRACTED KINKED NEEDLE SAFELY INTO SCOPE AND WITHDREW SCOPE BEFORE COMPLETELY REMOVING NEEDLE. REPLACE NEEDLE WITH OTHER 19G AND PROCEEDED. 5. WAS THE DEVICE USED IN A TORTUOUS POSITION? YES 6. ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? NOT OF THE KINKED NEEDLE BUT PROCEDURE IMAGES ARE AVAILABLE. PROCEDURE WAS UNSUCCESSFUL OSTENSIBLY DUE TO SCARRING OF EXCLUDED STOMACH. 7. WAS IT DAMAGED IN PACKAGING BEFORE REMOVAL? NOT THAT I'M AWARE OF 8. WAS IT DAMAGED ON REMOVAL FROM PACKAGING? NOT THAT I'M AWARE OF 9. WAS FORCE REQUIRED TO REMOVE THE DEVICE? YES FOR COMPLAINTS OCCURRING DURING USE (ONCE IN CONTACT WITH ENDOSCOPE) ALSO ASK: 10. WHAT IS THE ENDOSCOPE MANUFACTURER AND MODEL NUMBER THAT WAS USED? OLYMPUS LINEAR ECHOENDOSCOPE 11. WAS THE SCOPE RECENTLY SERVICED / REPAIRED? YES 12. WAS FORCE REQUIRED ON INSERTION OF DEVICE INTO SCOPE? NO 13. WHEN WAS THE ISSUED NOTED? E.G. ON ADVANCEMENT OF THE SHEATH/NEEDLE OR ON NEEDLE RETRACTION? ON RETRACTION 14. WHAT IS THE ENDOSCOPE MANUFACTURER AND MODEL NUMBER THAT WAS USED WITH THIS DEVICE? SEE #10 15. WAS DIFFICULTY EXPERIENCED WHILE RETRACTING THE NEEDLE? YES 16. WAS THE NEEDLE ABLE TO BE FULLY RETRACTED BEFORE REMOVING FROM THE PATIENT? NOT ATTEMPTED. JUST GOT THE BENT NEEDLE INTO THE SCOPE AND REMOVED SCOPE 17. WAS GAINING ACCESS TO THE TARGETED SITE DIFFICULT? YES 18. WAS THE ENDOSCOPE IN A FLEXED OR TWISTED POSITION AT ANY TIME DURING THE PROCEDURE? YES 19. WAS NEEDLE PENETRATION OF THE TARGETED SITE DIFFICULT? YES 20. WAS THE STYLET FULLY IN PLACE INSIDE THE NEEDLE WHEN ADVANCING INTO THE TARGETED SITE? NO 21. WAS THE STYLET PARTIALLY REMOVED PRIOR TO ADVANCEMENT OF NEEDLE? COMPLETELY REMOVED 22. HOW MANY BIOPSIES/PASSES WERE OBTAINED WITH USE OF THIS NEEDLE? N/A 23. DID ANY SECTION OF THE DEVICE DETACH INSIDE THE PATIENT? NO 24. IF KINKED BELOW THE SHEATH EXTENDER, DID THEY NOTICE THE KINK BEFORE PLACING THE DEVICE INTO THE SCOPE? N/A 25. WAS THERE DIFFICULTY OR SLIPPING EXPERIENCED OF THE SHEATH EXTENDER OR LOCK RING DURING USE? NO 26. WAS THERE DIFFICULTY IN ATTACHMENT / DETACHMENT OF THE LEUR TO THE SCOPE? NO 27. IF THE DEVICE IS PROCORE AND IT IS KINKED DISTALLY, IS THE KINK AT THE NOTCH / CORE TRAP? N/A THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE 21 AUGUST 2018. ON EVALUATION OF THE RETURNED DEVICE, THE DEVICE WAS RETURNED WITHOUT THE ORIGINAL PACKAGING. KINK AT THE SHEATH EXTENDER POSSIBLE ROOT CAUSE DUE TO RETURN OF DEVICE. DAMAGE NOTED ON SHEATH AT DISTAL END DUE TO NEEDLE BREAKING. NEEDLE TIP BROKE AT 57CM (SPECIFICATION FOR SHEATH HOLDER 143.5CM +1MM/-1MM,) KINK AT THE SHEATH EXTENDER. DAMAGE ON SHEATH EXTENDER AT THE POINT OF NEEDLE BREAKAGE. STYLET WAS NOT RETURNED. DUE TO KINK NEEDLE COULD NOT BE ADVANCED. VISUAL AND FUNCTIONAL WERE COMPLETED. COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. ROOT CAUSE A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER COMPLAINT WAS DETERMINED AS THE STYLET WAS NOT FULLY IN PLACE INSIDE THE NEEDLE WHEN ADVANCING INTO THE TARGETED SITE, AS INDICATED IN ADDITIONAL INFORMATION RECEIVED. THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE AS THE STYLET WAS NOT FULLY IN PLACE, AS PER ADDITIONAL INFORMATION RECEIVED. AS PER INSTRUCTION FOR USE, ¿STEP 6. ADVANCE NEEDLE INTO LESION. STEP 7. REMOVE STYLET FROM NEEDLE BY GENTLY PULLING BACK ON PLASTIC HUB SEATED IN METAL FITTING OF NEEDLE HANDLE. PRESERVE STYLET FOR USE IF ADDITIONAL CELL COLLECTION IS DESIRED." THEREFORE THE NEEDLE TIP BREAKAGE OCCURRED. DOCUMENT REVIEW AS THE ECHO-19 FROM UNKNOWN LOT NUMBER, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. PRIOR TO DISTRIBUTION, ALL ECHO-19 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 THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, WHICH ACCOMPANIES, ¿STEP 6. ADVANCE NEEDLE INTO LESION. STEP 7. REMOVE STYLET FROM NEEDLE BY GENTLY PULLING BACK ON PLASTIC HUB SEATED IN METAL FITTING OF NEEDLE HANDLE. PRESERVE STYLET FOR USE IF ADDITIONAL CELL COLLECTION IS DESIRED." THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. SUMMARY COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. THE RISK ASSOCIATED WITH THE COMPLAINT IS RISK CATEGORY IIA/LOW RISK LEVEL. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. 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.
510(K) NUMBER: K083330. INVESTIGATION IS STILL PENDING, A FOLLOW UP REPORT WILL BE SUBMITTED WITH THE INVESTIGATION CONCLUSIONS.
DEVICE EVALUATION: THE ECHO-19 DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, WITHOUT ITS ORIGINAL PACKAGING. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT BASED INVESTIGATION WAS CONDUCTED. LAB EVALUATION: THE DEVICES RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE 21ST AUGUST 2018. IN SUMMARY THE FOLLOWING RESULTS WERE OBSERVED IN THE LAB EVALUATION: ON EVALUATION OF THE RETURNED DEVICE, THE DEVICE WAS RETURNED WITHOUT THE ORIGINAL PACKAGING. KINK AT THE SHEATH EXTENDER POSSIBLE ROOT CAUSE DUE TO RETURN OF DEVICE. DAMAGE NOTED ON SHEATH AT DISTAL END DUE TO NEEDLE BREAKING. NEEDLE TIP BROKE AT 57CM (SPECIFICATION FOR SHEATH HOLDER 143.5CM +1MM/-1MM, REF. ¿DWG1084¿) KINK AT THE SHEATH EXTENDER. DAMAGE ON SHEATH EXTENDER AT THE POINT OF NEEDLE BREAKAGE. STYLET WAS NOT RETURNED. DUE TO KINK NEEDLE COULD NOT BE ADVANCED. VISUAL AND FUNCTIONAL WERE COMPLETED. DOCUMENT REVIEW INCLUDING IFU REVIEW: AS THE ECHO-19 DEVICES ARE FROM UNKNOWN LOT NUMBER, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. PRIOR TO DISTRIBUTION, ALL ECHO-19 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. THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, SE, IFU0101-1, WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER "THIS DEVICE IS USED TO SAMPLE TARGETED SUBMUCOSAL GASTROINTESTINAL LESIONS THROUGH THE ACCESSORY CHANNEL OF AN ULTRASOUND ENDOSCOPE." THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE, THE ECHO-19 DEVICE WAS USED TO ACCESS THE EXCLUDED STOMACH . A DEFINITIVE ROOT CAUSE COULD BE DETERMINED FROM THE AVAILABLE INFORMATION. FROM THE INFORMATION PROVIDED IT IS KNOWN THAT THE USER USED THE DEVICE OFF-LABEL, AS THE ECHO-19 WAS USED TO ACCESS THE EXCLUDED STOMACH, THIS WOULD BE OFF-LABEL USE. NEEDLE BREAKAGE OBSERVED DURING THE LABORATORY EVALUATION IS RELATED, THIS COULD HAVE OCCURRED DUE TO THE FACT THE PHYSICIAN/ASSISTANT USED THE DEVICE IN A SITUATION NOT SPECIFIED FOR INTENDED USE, WHEN THE DEVICE IS OUTSIDE ITS STATED INTENDED USE IN THIS CASE TO ACCESS THE EXCLUDED STOMACH. SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. 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.
AS REPORTED TO CUSTOMER RELATIONS "THE NEEDLE BROKE OFF IN THE PATIENT. THE BROKEN PART WAS RETRIEVED." UPDATE 18JUL2018 - PER REP - THE PROCEDURE LASTED THREE HOURS. THE DOCTOR STATED THAT THE NEEDLE DID NOT DISTEND WELL AND THE TIP BROKE DURING THE MANEUVER. DURING REMOVAL, THE 19GA TIP BROKE DURING THE MANEUVER. THEY SWITCHED OUT FOR A BOSTON NEEDLE. THE NEEDLE WAS JUST INSIDE THE DISTAL END OF THE SCOPE DURING REMOVAL. THEY PULLED THE NEEDLE OUT FROM THE BOTTOM.
AS REPORTED TO CUSTOMER RELATIONS "THE NEEDLE BROKE OFF IN THE PATIENT. THE BROKEN PART WAS RETRIEVED." UPDATE (B)(6) 2018 - PER REP - THE PROCEDURE LASTED THREE HOURS. THE DOCTOR STATED THAT THE NEEDLE DID NOT DISTEND WELL AND THE TIP BROKE DURING THE MANEUVER. DURING REMOVAL, THE19GA TIP BROKE DURING THE MANEUVER. THEY SWITCHED OUT FOR A BOSTON NEEDLE. THE NEEDLE WAS JUST INSIDE THE DISTAL END OF THE SCOPE DURING REMOVAL. THEY PULLED THE NEEDLE OUT FROM THE BOTTOM. UPDATE - (B)(6) 2018 - PER PHYSICIAN - THE PROCEDURE WAS AN EDGE PROCEDURE AND THE FNA NEEDLE WAS USED TO ACCESS THE EXCLUDED STOMACH IN A PATIENT WITH A HISTORY OF ROUX EN Y GASTRIC BYPASS, FOR INSTILLATION OF SALINE TO DISTENDED THE COLLAPSED (EXCLUDED) STOMACH.
THIS IS A FOLLOW UP REPORT. THE INVESTIGATION WAS RE-OPENED ON 08-OCT-2020 AS IT WAS THE FINAL FAILURE MODE APPLIED WAS DEEMED INCORRECT. THE INVESTIGATION IS STILL UNDERWAY AND A FINAL REPORT WILL BE SUBMITTED ONCE COMPLETED.
THE UPDATED INVESTIGATION WAS CONCLUDED ON THE (B)(6) 2020, THIS SUPPLEMENT REPORT IS BEING SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS WITHIN SECTION H.10
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 602896 | ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE | FGE CATHETER, BILIARY, DIAGNOSTIC | FGE | COOK IRELAND LTD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |