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

Model Number	G31520
Medical Device Problem Codes	Break (1069); Retraction Problem (1536); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	10/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
During the procedure the doctor noticed the 19g needle was rather stiff (didn`t move easily in and out of the sheet).While puncturing (2nd pass) something snapped and on the eus screen the noticed the needle seemed to have broken.They removed the needle and exchanged it for a 3-22.They finished the procedure without any problems.
Event or Problem Description
During the procedure the doctor noticed the 19g needle was rather stiff (didn`t move easily in and out of the sheet).While puncturing (2nd pass) something snapped and on the eus screen the noticed the needle seemed to have broken.They removed the needle and exchanged it for a 3-22.They finished the procedure without any problems.
Additional Manufacturer Narrative
Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
Additional Manufacturer Narrative
Device evaluation: (b)(4) unit of lot: c1339544 of echo-19 was returned opened in its original packaging.It should be noted that this file is related to another complaint file.For details of the other investigation please refer to (b)(4).Lab evaluation: the device involved in the complaint was evaluated in the laboratory on 20 nov 2019.The returned device lab findings and observations can be referred through the files.A kink proximal to the sheath extender was noted.This kink was difficult to see but could be felt during the lab evaluation.The sheath was observed to be broken below the sheath extender no needle break was observed.The distal needle tip was also observed to be damaged/deformed.A second pr was requested to be opened in relation to the deformed distal needle tip.This pr is (b)(4).Document review including ifu 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: c1622370 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: c1622370.The notes section of the instructions for use, ifu0101-1 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 (ifu0101-1).Root cause review: 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 excessive force which can be applied when trying to get the needle out of the scope during advancement.This could potentially have led to the needle kinking and sheath damage below the sheath extender.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.
Event or Problem Description
During the procedure the doctor noticed the 19g needle was rather stiff (didn`t move easily in and out of the sheet).While puncturing (2nd pass) something snapped and on the eus screen the noticed the needle seemed to have broken.They removed the needle and exchanged it for a 3-22.They finished the procedure without any problems.Fda mdr reporting required: reference d00055139 (dfmea0010), rev:017, section 13.1.3 "needle cannula kinks proximally (below the sheath extender)".Overall risk category i (high risk).No adverse effects to the patient was reported as occurring.A high risk rating indicates potential for injury to occur if the event was to recur.

• 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: 9322055
• Report Number: 3001845648-2019-00594
• Device Sequence Number: 2588892
• Product Code: FCG
• UDI-Device Identifier: 00827002315204
• UDI-Public: (01)00827002315204(17)200324(10)C1339544
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/12/2019

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: 03/24/2020
• Device Model Number: G31520
• Device Catalogue Number: ECHO-19
• Device Lot Number: C1339544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/03/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 10/18/2019
• Supplement Date Received by Manufacturer: 10/18/2019; 10/18/2019
• Initial Report FDA Received Date: 11/14/2019
• Supplement Report FDA Received Date: 12/12/2019; 01/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1