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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTS22, 12X100 KII Z-THR SLV, 12/BX GCJ

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APPLIED MEDICAL RESOURCES CTS22, 12X100 KII Z-THR SLV, 12/BX GCJ Back to Search Results
Model Number CTS22
Device Problem Physical Resistance (2578)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

The event device has been returned to applied medical for evaluation. A follow-up report will be provided upon completion of the investigation.

 
Event Description

Procedure performed: ni. Event description: "this is a complaint from the market. Administrative no. (b)(4). Please refer to the complaint sheet for investigation. Uncomfortable about resistance difference between firstly and subsequently inserting an instrument into trocar. Report from the sales rep: the customer felt resistance in firstly inserting a forceps into the trocar. During subsequently inserting it into the trocar, he was able to use the trocar without any problems. The surgery was successfully completed using this trocar. Any material fragmentations didn't occur. No patient injury. Request: the customer would like to know why he felt resistance in firstly inserting a forceps into the trocar and why feeling resistance wasn't replicated during subsequently inserting a forceps into the trocar. Please include the answer to these questions into closing letter. Initial investigation report: the event unit was returned to us and visually inspected. The septum was torn and not fragmented. The unit will be returned to amr for further evaluation. Admin# (b)(4)". Type of intervention: "the surgery was successfully completed using this trocar". Patient status: "no patient injury".

 
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Brand NameCTS22, 12X100 KII Z-THR SLV, 12/BX
Type of DeviceGCJ
Manufacturer (Section D)
APPLIED MEDICAL RESOURCES
22872 avenida empresa
rancho santa margarita CA 92688
Manufacturer Contact
wendy kobayashi
22872 avenida empresa
rancho santa margarita, CA 92688
9497138059
MDR Report Key7125683
MDR Text Key96029967
Report Number2027111-2017-02156
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
PMA/PMN NumberK060096
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,HEALTH PR
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/15/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/18/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device MODEL NumberCTS22
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/11/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/22/2017
Was Device Evaluated By Manufacturer? Yes
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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