ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE
Report
- Report Number
- 3001845648-2019-00057
- Event Type
- Malfunction
- Date Received
- February 15, 2019
- Report Date
- March 15, 2019
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FCG
- UDI-DI
- 00827002342798
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- 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: ED SUTKOWSKI, COOK MEDICAL INCORPORATED (CMI), 1025 ACUFF ROAD, P.O BOX 4195, BLOOMINGTON, INDIANA, 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. THIS CANCELLATION FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE CONFIRMATION THAT THIS COMPLAINT IS A DUPLICATE REPORT OF 248378 / MDR REPORT# 3001845648-2018-00615. UPDATE FROM REP ON 30-JAN-19 AS FOLLOWS: "I HAVE ONLY ONE COMPLAINT TRANSMITTED THE 5 OF DECEMBER 2019 FOR 1 X ECHO-HD-22-EBUS-P-C LOT C1527151." FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS IN BELGIUM WERE IN AGREEMENT. THIS COMPLAINT FILE IS BEING CLOSED /CANCELLED.
(B)(4). 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). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
COOK (B)(4) WERE INFORMED OF AN INCIDENT WITH THE ECHOTIP PROCORE ENDOBRONCHIAL HD ULTRASOUND BIOPSY NEEDLE BY (B)(6) REFERENCE# (B)(4) AS FOLLOWS: "WE HAVE BEEN INFORMED OF AN INCIDENT WITH THE ECHOTIP PROCORE ENDOBRONCHIAL HD ULTRASOUND BIOPSY NEEDLE (MODEL ECHO-HD-22-EBUS-P-C / G34279 ¿ LOT C1527151). INCIDENT DESCRIPTION: BROKEN NEEDLE. THE LOT NUMBER HAS BEEN CONFIRMED BUT THE HOSPITAL / COMPLAINT FACILITY BE CONFIRMED. INCIDENT DATE NOT CONFIRMED YET." WE SUSPECT THIS REPORT MAY BE A DUPLICATE REPORT OF COOK REFERENCE NUMBER (B)(4) / MDR REPORT# 3001845648-2018-00615. WE ARE AWAITING CONFIRMATION FROM (B)(6).
THIS CANCELLATION FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE CONFIRMATION THAT THIS COMPLAINT IS A DUPLICATE REPORT OF 248378 / MDR REPORT# 3001845648-2018-00615. UPDATE FROM REP ON 30-JAN-19 AS FOLLOWS: "I HAVE ONLY ONE COMPLAINT TRANSMITTED THE 5 OF DECEMBER 2019 FOR 1 X ECHO-HD-22-EBUS-P-C LOT C1527151." FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS IN BELGIUM WERE IN AGREEMENT. INTIAL REPORT DETAILS: COOK IRELAND WERE INFORMED OF AN INCIDENT WITH THE ECHOTIP PROCORE ENDOBRONCHIAL HD ULTRASOUND BIOPSY NEEDLE BY THE FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTSIN BELGIUM, FAGG.BE REFERENCE#26966 AS FOLLOWS: "WE HAVE BEEN INFORMED OF AN INCIDENT WITH THE ECHOTIP PROCORE ENDOBRONCHIAL HD ULTRASOUND BIOPSY NEEDLE (MODEL ECHO-HD-22-EBUS-P-C / G34279 ¿ LOT C1527151 ). INCIDENT DESCRIPTION: BROKEN NEEDLE. THE LOT NUMBER HAS BEEN CONFIRMED BUT THE HOSPITAL / COMPLAINT FACILITY BE CONFIRMED. INCIDENT DATE NOT CONFIRMED YET." WE SUSPECT THIS REPORT MAY BE A DUPLICATE REPORT OF COOK REFERENCE NUMBER 248378 / MDR REPORT# 3001845648-2018-00615. WE ARE AWAITING CONFIRMATION FROM FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS IN BELGIUM.
COOK IRELAND WERE INFORMED OF AN INCIDENT WITH THE ECHOTIP PROCORE ENDOBRONCHIAL HD ULTRASOUND BIOPSY NEEDLE BY THE FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTSIN BELGIUM, FAGG.BE (B)(4) AS FOLLOWS: "WE HAVE BEEN INFORMED OF AN INCIDENT WITH THE ECHOTIP PROCORE ENDOBRONCHIAL HD ULTRASOUND BIOPSY NEEDLE (MODEL ECHO-HD-22-EBUS-P-C / (B)(4) ¿ LOT C1527151 ). INCIDENT DESCRIPTION: BROKEN NEEDLE. THE LOT NUMBER HAS BEEN CONFIRMED BUT THE HOSPITAL / COMPLAINT FACILITY BE CONFIRMED. INCIDENT DATE NOT CONFIRMED YET." WE SUSPECT THIS REPORT MAY BE A DUPLICATE REPORT OF COOK REFERENCE NUMBER 248378 / MDR REPORT# 3001845648-2018-00615. WE ARE AWAITING CONFIRMATION FROM FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTSIN BELGIUM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 136734 | ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE | FCG KIT, NEEDLE, BIOPSY | FCG | COOK IRELAND LTD | G34279 | C1527151 | 00827002342798 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |