ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE
Report
- Report Number
- 3001845648-2018-00499
- Event Type
- Malfunction
- Date Received
- October 25, 2018
- Report Date
- October 25, 2018
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FCG
- UDI-DI
- 00827002315204
- PMA / PMN Number
- K083330
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
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: (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: 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: (B)(6). COOK MEDICAL INCORPORATED (CMI) (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). LAB EVALUATION THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON 24 OCT 2018. THE NEEDLE WAS FOUND TO BE BROKEN DISTALLY. DOCUMENT REVIEW: 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, IFU0101-0, WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER TO INSPECT THE DEVICE PRIOR TO USE FOR ANY DAMAGE: "VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN 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 (IFU0101-0). ROOT CAUSE REVIEW: THE FAILURE OF NEEDLE BROKEN WAS OBSERVED IN THE LABORATORY. A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER COMPLAINT COULD NOT BE DETERMINED AS CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN THE LABORATORY. A POSSIBLE CAUSE COULD BE ATTRIBUTED TO HARD LESION. SUMMARY: 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 INTERVENTION REQUIRING TISSUE SAMPLES, THE NEEDLE DECONSOLIDATED FROM THE REST OF THE DEVICE. THE NEEDLE DECONSOLIDATED AFTER BEING REMOVED FROM THE PATIENT. ANOTHER NEEDLE HAD TO BE DE-STERILIZED TO CONTINUE THE PROCEDURE. THE OPERATOR, TRAINED FOR SEVERAL YEARS AND USED TO WORKING WITH THIS DEVICE, HAD NOT ENCOUNTERED THIS KIND OF PROBLEM BEFORE."
AS PER SOURCE DOC (GOOGLE TRANSLATE) "DURING AN INTERVENTION REQUIRING TISSUE SAMPLES, THE NEEDLE DECONSOLIDATED FROM THE REST OF THE DEVICE. THE NEEDLE DECONSOLIDATED AFTER BEING REMOVED FROM THE PATIENT. ANOTHER NEEDLE HAD TO BE DE-STERILIZED TO CONTINUE THE PROCEDURE. THE OPERATOR, TRAINED FOR SEVERAL YEARS AND USED TO WORKING WITH THIS DEVICE, HAD NOT ENCOUNTERED THIS KIND OF PROBLEM BEFORE." UPDATE RECEIVED FROM REP 08NOV18: "THE CUSTOMER EXPRESSED HIMSELF BADLY IN THIS COMPLAINT. IT IS THE HANDLE THAT BROKE, NOT THE NEEDLE".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 844659 | ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE | FCG KIT, NEEDLE, BIOPSY | FCG | COOK IRELAND LTD | G31520 | C1424356 | 00827002315204 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |