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

Model Number G30550

Device Problems Component Incompatible (1108); Component or Accessory Incompatibility (2897)

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

Event Date 08/08/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4). Additional information: august 21, 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. The 1 x cst-10 device was returned to cook (b)(4) for evaluation. A lab evaluation was held on august 17, 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 (b)(4). Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Endoflex adapter did not fit the connection of the cystotome.

• 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: michael galvin ; o halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 6848259
• MDR Text Key: 85955159
• Report Number: 3001845648-2017-00385
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K022595
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 08/08/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: G30550
• Device Catalogue Number: CST-10
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/06/2017
• Event Location: Hospital
• Date Manufacturer Received: 08/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial