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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE; FCG KIT, NEEDLE, BIOPSY
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COOK IRELAND LTD ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE; FCG KIT, NEEDLE, BIOPSY Back to Search Results
Model Number G31520
Device Problem Material Deformation (2976)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/24/2018
Event Type  malfunction  
Manufacturer Narrative
510 (k) number; k083330.(b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
 
Event Description
As reported to customer relations: "during an endoscopic ultrasound.Aspirating a pseudocyst through the stomach wall.Punctured in with the needle and then aspirated an injected contrast.Attempted to pass guide wire through needle, and needle tip broke off into stomach wall from rest of catheter and sheath and had to be removed from scope.Successfully removed needle tip broken off from patient and used another device to complete procedure.Took needle tip out with snare.Tip not available, rest of device is available for return." additional information provided by mfg on 26nov2018: "following lab evaluation another failure mode was noted: kink at proximal end of sheath extender - based on the lab.The date aware should be the lab evaluation date ((b)(4) 2018).".
 
Event Description
This report is dealing with the proximal kink that was noted during the device evaluation.Correction to previous report submitted this is a product problem not an adverse event.The broken needle and required intervention is captured in a separate file.As reported to customer relations: "during an endoscopic ultrasound.Aspirating a pseudocyst through the stomach wall.Punctured in with the needle and then aspirated an injected contrast.Attempted to pass guide wire through needle, and needle tip broke off into stomach wall from rest of catheter and sheath and had to be removed from scope.Successfully removed needle tip broken off from patient and used another device to complete procedure.Took needle tip out with snare.Tip not available, rest of device is available for return." additional information provided by mfg on 26nov2018: "following lab evaluation another failure mode was noted: kink at proximal end of sheath extender - based on the lab.The date aware should be the lab evaluation date (14 nov 2018).".
 
Manufacturer Narrative
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 (b)(4).Importer site establishment registration number: (b)(4).Lab evaluation the device related to this occurrence underwent a laboratory evaluation on 14 nov 2018.The needle was found to be broken distally.A proximal kink was also observed during the lab evaluation.A new pr was requested to be opened for this extra failure mode.This report is capturing this additional failure mode.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.A review of the manufacturing records for echo-19 of lot number c1525135 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 c1525135.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" and "remove stylet from needle by gentle pulling back on plastic hub seated in metal fitting of needle handle".There is evidence to suggest that the customer did not follow the instructions for use (ifu0101-0) in relation to use of the stylet which was dealt in the original file.Root cause review the failure of needle kinked/bent was concluded from the available information.A definitive root cause for the customer complaint could not be determined as circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to re-packaging for transport returns as the deice was returned not in its original packaging.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.
 
Manufacturer Narrative
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), 1025 acuff road, p.O box 4195, bloomington, indiana 47402-4195.Importer site establishment registration number: (b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
 
Event Description
As reported to customer relations: "during an endoscopic ultrasound.Aspirating a pseudocyst through the stomach wall.Punctured in with the needle and then aspirated an injected contrast.Attempted to pass guide wire through needle, and needle tip broke off into stomach wall from rest of catheter and sheath and had to be removed from scope.Successfully removed needle tip broken off from patient and used another device to complete procedure.Took needle tip out with snare.Tip not available, rest of device is available for return." additional information provided by mfg on 26nov2018: "following lab evaluation another failure mode was noted: kink at proximal end of sheath extender - based on the lab.The date aware should be the lab evaluation date (14 nov 2018).".
 
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Brand Name
ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE
Type of Device
FCG KIT, NEEDLE, BIOPSY
Manufacturer (Section D)
COOK IRELAND LTD
o halloran road
limerick
MDR Report Key8155185
MDR Text Key131324675
Report Number3001845648-2018-00575
Device Sequence Number1
Product Code FCG
UDI-Device Identifier00827002315204
UDI-Public(01)00827002315204(17)210730(10)C1525135
Combination Product (y/n)N
PMA/PMN Number
K083330
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 01/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/30/2021
Device Model NumberG31520
Device Catalogue NumberECHO-19
Device Lot NumberC1525135
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2018
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/12/2018
Event Location Hospital
Date Manufacturer Received11/27/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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