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

Model Number	G30550
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/19/2017
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.Investigation is pending.A follow up mdr will be submitted with the investigation conclusions.
Event or Problem Description
The user opened the package and found the tip of the device was crooked, so the user change another new device to continue the procedure.
Additional Manufacturer Narrative
Cook ireland ltd (manufacturer) is submitting this report on behalf of cook (b)(4).Exemption number: e2016031.Importer site contact and address: (b)(4).Importer site establishment registration number: (b)(4).Lab evaluation: 1 x cst-10 device of lot # c1255944 was returned to cirl for evaluation.A lab evaluation was held on 24th oct 2017.On evaluation of the returned device, the tip of the device was found to be bent in the sealed package.The photograph from the complaint was also evaluated as part of the investigation.Root cause: a definitive root cause for the customer complaint could not be determined as the exact transport and storage conditions of use could not be replicated in the laboratory setting.A possible cause of this complaint may be that the device was damaged during transportation or external storage.The complaint is confirmed as the failure was verified in the laboratory as the tip of the device was bent.The customer complaint "the tip of the device was crooked" is also confirmed as the tip of the device was crooked in the photograph.Documents review: a review of the manufacturing records for cst-10 devices of lot # c1255944 did not reveal any discrepancies which could have contributed to this complaint issue.Ifu review: as per the instructions for use, the user is instructed as follows: "visually inspect with particular attention to kinks, bends or breaks.If an abnormality is detected that would prohibit proper working condition, do not use".Due to the inspection of the packaging at post-steri qc and packaging qc it is not likely the damage to the device occurred at cook ireland.If the tip was damaged it would have been noted during the fqc / packaging process therefore it was most likely the tip was damaged during transportation or external storage.Summary: the complaint is confirmed as the failure was verified in the laboratory as the tip of the device was bent.The customer complaint "the tip of the device was crooked" is also confirmed as the tip of the device was crooked in the photograph.From the complaint information reported the issue was noted prior to patient contact before opening the package therefore the patient did not experience any adverse effects due to this occurrence.The risk for this complaint has been assessed and has been determined to be low.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
This follow up mdr is being submitted to include the investigation conclusions.The user opened the package and found the tip of the device was crooked, so the user change another new device to continue the procedure.

• 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: 6964827
• Report Number: 3001845648-2017-00475
• Device Sequence Number: 1324672
• Product Code: KNS
• UDI-Device Identifier: 00827002305502
• UDI-Public: (01)00827002305502(17)190725(10)C1255944
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2017

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 Model Number: G30550
• Device Catalogue Number: CST-10
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/20/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 09/21/2017
• Supplement Date Received by Manufacturer: 09/21/2017
• Initial Report FDA Received Date: 10/20/2017
• Supplement Report FDA Received Date: 11/16/2017
• Patient Sequence Number: 1