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

Model Number	G31520
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Date of Event	06/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pma/510(k) #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)(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.
Event or Problem Description
About 3 inches broke off of the needle inside a patient.The needle was used to access the cyst-gastric cavity.The physician was able to retrieve the piece that was left in the patient.Staff nor physician noted anything untoward with the needle during set-up or initial use.
Event or Problem Description
About 3 inches broke off of the needle inside a patient.The needle was used to access the cyst-gastric cavity.The physician was able to retrieve the piece that was left in the patient.Staff nor physician noted anything untoward with the needle during set-up or initial use.
Additional Manufacturer Narrative
Pma/510(k) #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).Importer site establishment registration number:(b)(4).1 unit of echo-19 of lot c1553239 was returned opened not in its original packaging.The device related to this occurrence underwent a laboratory evaluation.The needle was found to be broken distally and the needle tip was also found to be damaged.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 c1553239 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 c1553239.The notes section of the instructions for use, which accompanies this device instructs the user to; "if an abnormality is detected that would prohibit proper working condition, do not use".There is no evidence to suggest that the customer did not follow the instructions for use.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 advancement into a hard lesion.It is likely that the needle tip was damaged initially resulting in the distal end of the needle breaking after.Complaint is confirmed as the failure was verified in the laboratory.The tip of the needle was misplaced but confirmed that no portion of the device is inside the scope or patient.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
About 3 inches broke off of the needle inside a patient.The needle was used to access the cyst-gastric cavity.The physician was able to retrieve the piece that was left in the patient.Staff nor physician noted anything untoward with the needle during set-up or initial use.
Additional Manufacturer Narrative
Pma/510(k) #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).Importer site establishment registration number: 3005580113 complaint device was not returned therefore a document based review will be performed.It was indicated that complaint device was to be returned but has not been returned to date.If it is returned in the future then the file will be updated accordingly.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 c1553239 did not reveal any discrepancies that could have contributed to this complaint issue.The notes section of the instructions for use, which accompanies this device instructs the user to; "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 that the customer did not follow the instructions for use.A definitive root cause could not be determined from the available information.The failure of needle broken was concluded from the available information.A definitive root cause could not be determined from the available information.A possible cause could be attributed to hard lesion, as per additional information received the needle broke in the cyst-gastric cavity.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.

• Brand Name: ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE
• Common Device Name: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8783927
• Report Number: 3001845648-2019-00324
• Device Sequence Number: 19255089
• Product Code: FCG
• UDI-Device Identifier: 00827002315204
• UDI-Public: (01)00827002315204(17)211105(10)C1553239
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K083330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/05/2021
• Device Model Number: G31520
• Device Catalogue Number: ECHO-19
• Device Lot Number: C1553239
• 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: 06/14/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/14/2019
• Supplement Date Received by Manufacturer: 07/14/2019; 06/14/2019
• Initial Report FDA Received Date: 07/12/2019
• Supplement Report FDA Received Date: 08/08/2019; 09/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR
• Patient Weight: 81