ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE
Report
- Report Number
- 3001845648-2018-00128
- Event Type
- Malfunction
- Date Received
- March 16, 2018
- Date of Event
- February 1, 2018
- Report Date
- May 15, 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 PENDING, A FOLLOW UP MDR WILL BE SUBMITTED WITH 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 (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). DEVICE EVALUATION: THE ECHO-HD-22-EBUS-P-C OF LOT NUMBER C1253872 DEVICE INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, WITHOUT ORIGINAL PACKAGING. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT BASED INVESTIGATION WAS CONDUCTED. FROM CUSTOMER TESTIMONY, IT WAS KNOWN THE CUSTOMER ADVANCED THE NEEDLE THROUGH THE SCOPE AND BENT IT A LITTLE WITH THE ELEVATOR. TO SEE IF IT WORKS HE PROTRUDED THE NEEDLE THEN. HE FELT THAT IT WAS A LITTLE BIT JUMPY AND DECIDED NOT TO USE IT IN A PATIENT. THIS ALL WAS DONE OUTSIDE THE PATIENT, BUT NOT OUTSIDE THE SCOPE ON EVALUATION OF THE RETURNED DEVICE IT WAS OBSERVED THAT DEVICE RETURNED IN PLASTIC BAG. STYLET RETURNED WITH THE DEVICE. IT WAS NOTED THAT THERE WAS NO NEEDLE EXPOSURE. THE NEEDLE ADVANCES AND RETRACTS WITHOUT ISSUE. THERE WAS EVIDENCE OF SLIGHT BEND BELOW THE SHEATH EXTENDER. IT WAS FOUND THAT THE STYLET WILL NOT RE-INSERT THE CUSTOMER COMPLAINT IS CONSIDERED TO BE CONFIRMED AS THE COMPLAINT WAS VERIFIED IN LABORATORY. THERE WAS EVIDENCE OF SLIGHT BEND BELOW THE SHEATH EXTENDER. IT IS POSSIBLE THAT THIS OCCURRED WHILE ATTACHING AND DETACHING THE DEVICE FROM THE SCOPE CAUSING THE NEEDLE TO BEND BELOW THE SHEATH EXTENDER. ROOT CAUSE: CAPA (B)(4) WAS RAISED IN RELATION TO THIS ISSUE AND IT WILL DEAL WITH ANY ACTIONS IDENTIFIED. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS. 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. A REVIEW OF THE MANUFACTURING RECORDS FOR ECHO-HD-22-EBUS-P-C DEVICE OF LOT# C1253872 DID NOT REVEAL ANY DISCREPANCIES WHICH COULD HAVE CONTRIBUTED TO THIS OCCURRENCE. THERE IS NO EVIDENCE TO SUGGEST THAT THIS ISSUE EFFECTS THE ENTIRE LOT # C1253872; UPON REVIEW OF COMPLAINTS THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT # C1253872. IFU REVIEW: THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, IFU0110-5 WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER TO; "VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE, IT STATES IN THE IFU THAT A PENTAX EBUS SCOPE IS INTENDED TO BE USED WITH THE DEVICE. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE (IFU0110-5). FROM THE INFORMATION PROVIDED: THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. SUMMARY: THE CUSTOMER COMPLAINT IS CONSIDERED TO BE CONFIRMED AS THE COMPLAINT WAS VERIFIED IN LABORATORY. FROM THE INFORMATION PROVIDED: THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE THE RISK ASSOCIATED WITH THIS COMPLAINT IS RISK CATEGORY III/NO RISK LEVEL. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR ANY 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 (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). THIS FOLLOW UP REPORT IS BEING SUBMITTED TO CANCEL THE INITIAL MDR REPORT. AFTER THE SUBMISSION OF THE INITIAL REPORT , UPDATES WERE MADE TO COOK IRELAND¿S RISK MANAGEMENT SYSTEM IN ACCORDANCE WITH ISO4971. 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 DISTAL AND PROXIMAL NEEDLE KINKS ON ECHO EBUS DEVICES HAVE REDUCED, AND ARE NOW IDENTIFIED AS LOW RISK. THIS CASE WERE INITIALLY REPORTED ON THE DESCRIPTION OF A PROXIMAL NEEDLE KINK. A SERIOUS DETERIORATION IN THE STATE OF HEALTH OF THE PATIENT WAS NOT REPORTED IN THIS CASE. THE INITIAL ASSESSMENT WAS BASED ON THE CURRENT RISK AT THE TIME FOR THOSE FAILURE MODES WITHIN THE ORIGINAL RISK DOCUMENTATION AND THE CASE WAS REPORTED BASED ON POTENTIAL FOR HARM TO OCCUR AS PER SECTION 803.50 OF 21 CFR 803 FDA MDR REPORTING IS NOT REQUIRED. OVERALL RISK ASSESSED AS CATEGORY IIA (LOW).
STOCKING MOVEMENT OF NEEDLE BECAUSE ENDOSCOPE WAS CURVED. " AS PER COMPLAINT FORM": THE NEEDLE WAS PROTRUDED INTO THE BRONCHOSCOPE PREVIOUS TO TREATING THE PATIENT. THE BRONCHOSCOPE WAS IN SLIGHTLY BENT POSITION. THE NEEDLE COULD BE EXTENDED ONLY JUMPY AND THE USER DECIDED NOT TO USE IT IN THE PATIENT. DOCTOR USED ANOTHER NEEDLE FROM THE SAME LOT WITHOUT ANY PROBLEMS.
STOCKING MOVEMENT OF NEEDLE BECAUSE ENDOSCOPE WAS CURVED. " AS PER COMPLAINT FORM": THE NEEDLE WAS PROTRUDED INTO THE BRONCHOSCOPE PREVIOUS TO TREATING THE PATIENT. THE BRONCHOSCOPE WAS IN SLIGHTLY BENT POSITION. THE NEEDLE COULD BE EXTENDED ONLY JUMPY AND THE USER DECIDED NOT TO USE IT IN THE PATIENT. DOCTOR USED ANOTHER NEEDLE FROM THE SAME LOT WITHOUT ANY PROBLEMS DURING THE DEVICE EVALUATION A PROXIMAL NEEDLE KINK WAS NOTED.
A FOLLOW UP REPORT IS BEING SUBMITTED TO CANCEL THE INITIAL MDR REPORT. STOCKING MOVEMENT OF NEEDLE BECAUSE ENDOSCOPE WAS CURVED. " AS PER COMPLAINT FORM": THE NEEDLE WAS PROTRUDED INTO THE BRONCHOSCOPE PREVIOUS TO TREATING THE PATIENT. THE BRONCHOSCOPE WAS IN SLIGHTLY BENT POSITION. THE NEEDLE COULD BE EXTENDED ONLY JUMPY AND THE USER DECIDED NOT TO USE IT IN THE PATIENT. DOCTOR USED ANOTHER NEEDLE FROM THE SAME LOT WITHOUT ANY PROBLEMS DURING THE DEVICE EVALUATION A PROXIMAL NEEDLE KINK WAS NOTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 189042 | ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE | FCG KIT, NEEDLE, BIOPSY | FCG | COOK IRELAND LTD | G34279 | 00827002342798 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |