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U.S. Department of Health and Human Services

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

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COOK IRELAND LTD CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE KNS UNIT, ELECTROSURGICAL, ENDOSCOPIC Back to Search Results
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.
 
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Brand NameCYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE
Type of DeviceKNS 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 Key6848259
MDR Text Key85955159
Report Number3001845648-2017-00385
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K022595
Number of Events Reported1
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 Received09/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG30550
Device Catalogue NumberCST-10
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/06/2017
Event Location Hospital
Date Manufacturer Received08/08/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/07/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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