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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
Catalog Number ECHO-HD-25-C
Device Problems Retraction Problem (1536); Material Twisted/Bent (2981)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
Once the needle was introduced into the operating channel of the endoscope to perform a biopsy it was not possible to make the needle come out of the sheath. The needle was replaced and the biopsy was then performed "as per cc form": once the needle was introduced into the operating channel of the endoscope to perform a biopsy it was not possible to make the needle come out of the sheat. The needle was replaced and the biopsy was performed customer request credit note. Was it possible to fully retract the needle into the sheath before removing the device from the patient? no the tip was a little bit out of the sheath a section of the device did not remain inside the patient¿s body. The patient did not require any additional procedures due to this occurrence. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence. Are images of the device or procedure available? n/a, yes, no. If the report involves a kink or bend in the needle, where is this located on the device (handle end (proximal end) or patient end (distal end))? n/a, handle end, patient end. Were any other defects (other than the complaint issue) observed on the device prior to return (e. G. Kink)? n/a, yes, no please specify if yes. If the device was kinked below the sheath extender, was the kink observed before inserting the device into the scope? n/a, yes, no. If the device is a procore needle, is the device damage located at the notch / core trap? n/a, yes, no if no, please specify where the damage is located: _____________________. Was gaining access to the target site difficult? n/a, yes, no. Was the device used in a tortuous position? n/a, yes, no. Was puncture of the target site difficult? n/a, yes, no. Please describe the anatomical location of the intended target site (pancreas, stomach, lungs etc. ). Pancreas. If the lungs, which lymph node was being targeted? e. G. 4r, 11r, 12l etc. Please describe the size of the intended target site. Na. If not with the device in question, how was the procedure performed and/or finished? new device, same procedure. Was the device damaged in packaging prior to removal? n/a, yes, no. Was the device damaged on removal from packaging? n/a, yes, no. Was force required to remove the device? n/a, yes, no. Did the patient require any additional procedures as a result of this event? n/a, yes, no. What intervention (if any) was required?. Was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? n/a, same procedure, another day no secondary intervention, another needle was used in the same procedure. Were any other defects observed on the device prior to return (e. G. Kinks, bends, breaks etc. )? n/a, yes, no. If yes, please specify what was observed and where on the device it was observed. What is the scope manufacturer and model number that was used? olympus-gf-uct180. Was resistance felt while inserting the device through the scope? n/a, yes, no. Was the scope recently serviced / repaired? n/a, yes, no. When was the issued with the product noted? on advancement of the sheath/needle or on needle retraction?. Was the syringe used during the procedure, after the stylet was removed? n/a, yes, no. Was difficulty experienced while retracting the needle? n/a, yes, no. Was it possible to fully retract the needle into the sheath before removing the device from the patient? n/a, yes, no the tip was a little bit out of the sheat. Was the endoscope in a flexed or twisted position at any time during the procedure? n/a,yes,no. Was the stylet partially removed when advancing the needle into the target site? n/a,yes,no. How many samples were obtained (passes completed) with this needle? no samples. Did any section of the device detach inside the patient? n/a, yes, no if yes, please specify:. Was there difficulty locking the sheath (or needle) in place or slipping experienced during use? n/a, yes, no. Was there difficulty in attaching or detaching the device to the accessory channel port on the scope? n/a, yes, no. When the needle tip was advanced into the target site was the distal scope position adjusted so as to strain or flex the needle? n/a, yes, no. If an ebus procedure did the needle tip hit the cartilage rings of the trachea?.
 
Manufacturer Narrative
510(k) number: k142688 complaint device was not returned therefore a document based review will be performed. Prior to distribution, all echo-hd-25-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 cook (b)(4) a review of the manufacturing records for echo-hd-25-c of lot number c1716795 did not reveal any discrepancies that could have contributed to this complaint issue. The review of relevant manufacturing records confirms the failure mode has not previously occurred with the current lot number. Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1716795. The notes section of the instructions for use, ifu0077-4, which accompanies this device instructs the user to inspect the device prior to use: "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 the user did not follow the ifu. A definitive root cause could not be determined from the available information. A possible root cause could be attributed to tortuous position and difficult target site requiring flexed endoscope position as per additional information potentially causing the needle to kink distally and not advance from the sheath complaint is confirmed based on the customer's testimony. 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.
 
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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
MDR Report Key11278440
MDR Text Key280450803
Report Number3001845648-2021-00049
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial
Report Date 01/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberECHO-HD-25-C
Device Lot NumberC1716795
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location Hospital
Date Manufacturer Received12/16/2020
Is This a Reprocessed and Reused Single-Use Device? No

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