ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE
Report
- Report Number
- 3001845648-2018-00195
- Event Type
- Malfunction
- Date Received
- April 30, 2018
- Date of Event
- April 2, 2018
- Report Date
- April 30, 2018
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FCG
- UDI-DI
- 00827002347854
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
510(K) NUMBER: K142688. 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 REPORT WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
510(K) NUMBER: K142688. 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). INVESTIGATION IS STILL PENDING, A FOLLOW REPORT WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
510(K) NUMBER: K142688. 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), 1025 ACUFF ROAD, P.O BOX 4195, BLOOMINGTON, INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). 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 DISTAL AND PROXIMAL NEEDLE KINKS ON ECHO-HD-XX-C 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.
ADVANCE AND RETRIEVE WAS DIFFICULT AT DESIRED LESION LOCATION DURING THE FIRST ATTEMPT OF BIOPSY. OPERATOR RETRIEVED THE DEVICE FROM ENDOSCOPE AND CHECKED THE TIP OF THE NEEDLE, FOUND OUT THERE IS A KINK AT SIDE SLOT.
ADVANCE AND RETRIEVE WAS DIFFICULT AT DESIRED LESION LOCATION DURING THE FIRST ATTEMPT OF BIOPSY. OPERATOR RETRIEVED THE DEVICE FROM ENDOSCOPE AND CHECKED THE TIP OF THE NEEDLE, FOUND OUT THERE IS A KINK AT SIDE SLOT.
THIS REPORT IS BEING SUBMITTED TO CANCEL THE INITIAL MDR REPORT. ADVANCE AND RETRIEVE WAS DIFFICULT AT DESIRED LESION LOCATION DURING THE FIRST ATTEMPT OF BIOPSY. OPERATOR RETRIEVE THE DEVICE FROM ENDOSCOPY AND CHECK THE TIP OF THE NEEDLE FOUND OUT THERE IS A KINK AT SIDE SLOT. ADDITIONAL INFORMATION RECEIVED TO CONFIRM THE NEEDLE WAS FULLY RETRACTED PRIOR TO PATIENT REMOVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 316746 | ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE | FCG KIT, NEEDLE, BIOPSY | FCG | COOK IRELAND LTD | G34785 | C1391867 | 00827002347854 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |