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

Model Number	G52012
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) # k092359.Cook (b)(4) ltd (manufacturer) is submitting this report on behalf of (b)(6) (importer).Exemption number: e2016031.Information pertaining manufacturer 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.
Event or Problem Description
The doctor inserted the echo-hd-19-a through the scope.He adjusted the angle and pushed the handle to puncture.However, the handle was not pressed well and the needle did not come out either.The nurse pulled the echo-hd-19-a out and found that sheath was broken.The end of the sheath was hanging broken.The doctor guessed the cause of the sheath being broken - when he pushed the handle, the needle pierced the bent sheath.So sheath was broken.
Event or Problem Description
The doctor inserted the echo-hd-19-a through the scope.He adjusted the angle and pushed the handle to puncture.However, the handle was not pressed well and the needle did not come out either.The nurse pulled the echo-hd-19-a out and found that sheath was broken.The end of the sheath was hanging broken.The doctor guessed the cause of the sheath being broken, when he pushed the handle, the needle pierced the bent sheath.So sheath was broken.
Additional Manufacturer Narrative
Pma/510(k)#: k092359.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).The echo-hd-19-a device of lot number: c1588829 involved in this complaint was returned for evaluation, with the original packaging.The packaging was open on receipt.With the information provided, a physical examination and document based investigation was conducted.The device related to this occurrence underwent a laboratory evaluation on the 08aug2019 and 18sep2019.There was a kink at the distal end of the needle.Damage to the sheath was observed.Needle able to advance and retract without issue.Prior to distribution, all echo-hd-19-a 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 relevant manufacturing records (c1588829) revealed no discrepancies that could have contributed to this complaint.Upon review of complaints, this failure mode has not occurred previously with this 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: c1588829.There is no evidence to suggest that the customer did not follow the instructions for use.A definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to the needle kinking distally when advancing the device through the endoscope which was in a tortuous position, which may in turn have caused the sheath damage.Complaint is confirmed as the failure was verified in the laboratory.There was a kink at the distal end of the needle.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.
Additional Manufacturer Narrative
Pma/510(k)#: k092359.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).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
The doctor inserted the echo-hd-19-a through the scope.He adjusted the angle and pushed the handle to puncture.However, the handle was not pressed well and the needle did not come out either.The nurse pulled the echo-hd-19-a out and found that sheath was broken.The end of the sheath was hanging broken.The doctor guessed the cause of the sheath being broken - when he pushed the handle, the needle pierced the bent sheath.So sheath was broken.

• Brand Name: ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE
• Common Device Name: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8842055
• Report Number: 3001845648-2019-00377
• Device Sequence Number: 11479022
• Product Code: FCG
• UDI-Device Identifier: 00827002520127
• UDI-Public: (01)00827002520127(17)220225(10)C1588829
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K092359
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/25/2022
• Device Model Number: G52012
• Device Catalogue Number: ECHO-HD-19-A
• Device Lot Number: C1588829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/30/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/04/2019
• Supplement Date Received by Manufacturer: 07/04/2019; 07/04/2019
• Initial Report FDA Received Date: 07/30/2019
• Supplement Report FDA Received Date: 08/27/2019; 09/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1