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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY

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COOK IRELAND LTD ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY Back to Search Results
Model Number G34785
Device Problem Break (1069)
Patient Problems Abscess (1690); Foreign Body In Patient (2687)
Event Date 07/22/2019
Event Type  Injury  
Manufacturer Narrative
Pma/510(k) #k142688. Investigation is still pending. A follow up mdr will be submitted to include the investigation conclusions.
 
Event Description
Needle tip broken into the patient, patient is today going well but after examination he did an abscess. They performed a scanner for confirmation and they could see needle tip around 1 cm into the lesion. Lesion was in the pancreas tail, very hard lesion. Dr made 2 pass and the needle broke at the second. As per completed customer complaint form: customer opened the sealed package without problem. They checked the device before to use, all seemed ok. They performed eus examination and decided to do punction. Lesion was in pancreas tail, and encho endoscope was not too much bending. They performed the first punction but lesion was very hard like a stone lesion, they get sample and decided to do second punction. Tip of the needle was a little bend but seemed not weakened. They performed the second punction and they removed the device from the scope they saw that tip of the needle was missing. They did a third punction with acquire needle and stop examination. At this moment they didn't know that tip of the needle was inside the patient. Some day later patient was painful and they did a scanner (crt) and they could see the tip of the needle into the lesion. Patient is still at the hospital, it is not painful for her but she probably should have a pancreas surgery for removing the lesion with the tip of the needle inside it. A quality defect report was received from the complaint facility on (b)(6) 2019 details of the incident: date of the incident: (b)(6) 2019: hepatic biopsy puncture under general anesthesia for a tumour at the top of the pancreas on the second stroke of the needle, the needle bent. Potential clinical consequences: patient returned on (b)(6) 2019 for abdominal pain with fever. The scan showed an abscess on the tumoral lesion at the bottom of the pancreas with a metal foreign body, likely a needle fragment. Occurred in unit digestive-system endoscopy the device in question has not been kept. "incident information: date of occurrence: (b)(6) 2019. Description of the incident: (b)(6) 2019: liver biopsy punction for tumor of the head of the pancreas under general anesthesia. In the second passage of the needle, it is bent. (b)(6) 2019: patient returns for febrile abdominal pain. Ct scan shows abscess of tumor lesion of pancreatic tail with metallic foreign body probably corresponding to the needle piece. Patient information: current state of the patient: re-hospitalization (duration 15 days from (b)(6) 2019 to (b)(6) 2019) for febrile abdominal pain. Realization of a scanner highlighting a collection abscessed post-biopsy beginning in contact with the pancreatic lesion and containing within it a metallic foreign body. Antibiotic treatment and drainage of the abscess with removal of the foreign body. Actions undertaken in the facility: the needle piece could not be kept. ".
 
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Brand NameECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE
Type of DeviceFCG KIT, NEEDLE, BIOPSY
Manufacturer (Section D)
COOK IRELAND LTD
o halloran road
limerick
Manufacturer (Section G)
COOK IRELAND LTD
o halloran road
national technology park
limerick
Manufacturer Contact
heather ryan
o halloran road
national technology park
limerick 
061334440
MDR Report Key8954713
MDR Text Key161168144
Report Number3001845648-2019-00447
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/24/2022
Device Model NumberG34785
Device Catalogue NumberECHO-HD-3-20-C
Device Lot NumberC1579217
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/22/2019
Event Location Hospital
Date Manufacturer Received08/06/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/24/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/03/2019 Patient Sequence Number: 1
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