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

Model Number	G30550
Medical Device Problem Codes	Component Incompatible (1108); Component or Accessory Incompatibility (2897)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/08/2017
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: ed sutkowski cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195.Importer site establishment registration number: 3005580113.Additional information 21 august 2017 ¿the customer is using a endoflex adapter.¿ this observation was found, prior to point of use.There was no impact to a patient or end user.1 x cst-10 device was returned to cirl for evaluation.A lab evaluation was held on 17 august 2017.Upon evaluation of the returned device, an active cord (acu-1) was able to connect to the cst-10 device.No other defects were observed.This complaint is confirmed on customer testimony.A definitive root cause for the customer complaint could not be determined.However, it is possible that the endoflex adapter was not compatible with the device.It may be noted that according to ifu0005-9, the user is instructed to visually inspect the device ¿if any abnormality is detected that would prohibit proper working condition, do not use¿.Prior to distribution all cst devices are subject to visual inspection to ensure device integrity.These inspections are outlined in internal procedures in place at cook ireland.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
Endoflex adapter did not fit the connection of the cystotome.

• 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: 6848259
• Report Number: 3001845648-2017-00385
• Device Sequence Number: 19190166
• Product Code: KNS
• UDI-Device Identifier: 00827002305502
• UDI-Public: (01)00827002305502(17)180907(10)C1148755
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 08/08/2017

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: 09/06/2017
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2017
• Initial Report FDA Received Date: 09/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1