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

Catalog Number CST-10

Device Problems Break (1069); Device Damaged Prior to Use (2284)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/10/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 (b)(4) 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 (b)(4) 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 (b)(4).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 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
• Type of Device: KNS UNIT, ELECTROSURGICAL, ENDOSCOPIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer Contact: tracy o'sullivan ; o'halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 6402476
• MDR Text Key: 69957102
• Report Number: 3001845648-2017-00090
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 00827002305502
• UDI-Public: (01)00827002305502(17)190909(10)C1270422
• Combination Product (y/n): N
• PMA/PMN Number: K022595
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CST-10
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/13/2017
• Event Location: Hospital
• Date Manufacturer Received: 02/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1