MAUDE Adverse Event Report: COOK IRELAND LTD CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE; KNS UNIT, ELECTROSURGICAL, ENDOSCOPIC

Catalog Number	CST-10
Medical Device Problem Codes	Break (1069); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.The customer reported the following complaint issue "defect before use in patient" "as per complaint form": product broke before use in the bag." the cst-10 device of lot c1270422 was returned to cirl for an evaluation.The cst-10 device involved in this complaint was returned opened in its original packaging.On evaluation of the returned device the white handle was found to be broken.It was noted during the lab evaluation that the damage sustained by the white component was indicative of transport damage where an external force was exerted on the product.It was noted that due to numerous checks the device would not have left cirl damaged.The customer complaint was confirmed on evaluation of the returned device.A review of the manufacturing records fro the cst-10 device of lot c1270422 did not reveal any discrepancies that could have contributed to this event.There was one unit scrapped at final quality control checks(fqc); the non conformance code used was "component not secure".As this non-conformance was detected at fqc, there is no evidence to suggest that this is related to the complaint event.There is no evidence to suggest that this issue affects the entire lot # c1270422; upon review of complaints this failure mode has not occurred previously with this lot # c1270422.A review of the incoming quality control record for the component involved in this complaint did not reveal any discrepancies that could have contributed to this issue.Prior to distribution all cst-10 devices are subject to 100% inspection to ensure device integrity, these inspections and functional checks are outlined in internal procedures in place at cirl.According to the instructions for use notes section, the user is instructed 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." it should be noted that the customer states that the stent was found to be broken prior to use/ contact with the patient.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
Defect before use in patient "as per complaint form": product broke before use in the bag.Picture provided indicated white handle was broken.

• Brand Name: CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE
• Common Device Name: KNS UNIT, ELECTROSURGICAL, ENDOSCOPIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 6402476
• Report Number: 3001845648-2017-00090
• Device Sequence Number: 13611814
• Product Code: KNS
• UDI-Device Identifier: 00827002305502
• UDI-Public: (01)00827002305502(17)190909(10)C1270422
• Combination Product (Y/N): N
• PMA/510(K) Number: K022595
• 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
• Report Date (Section B): 02/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: CST-10
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/13/2017
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2017
• Initial Report FDA Received Date: 03/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1