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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTF03, 5X100 KII FIOS Z-THR 6/BX GCJ

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APPLIED MEDICAL RESOURCES CTF03, 5X100 KII FIOS Z-THR 6/BX GCJ Back to Search Results
Model Number CTF03
Device Problem Physical Resistance (2578)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

The event device is anticipated to return to applied medical for evaluation. A follow-up report will be provided upon completion of investigation. This report is to follow up medwatch report # (b)(4).

 
Event Description

Procedure performed: "umbilical hernia repair". Event description: medwatch report # (b)(4) received via mail on 25-apr-2018: date of event: (b)(6) 2018. A (b)(6) year old female, not hispanic/latino ethnicity. "during the use of the trocar, the scope did not fit into the device. " additional information was received via telephone from implementation specialist on monday 7-may-2018 at 11:17 am: rep stated he was not in the case. The facility was using the new [scope brand] system, which uses a larger outer diameter which led the scope to getting stuck on the fios obturator. Surgeon was dr. []. The device will be returning, but is with risk management. Patient status: no patient injury.

 
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Brand NameCTF03, 5X100 KII FIOS Z-THR 6/BX
Type of DeviceGCJ
Manufacturer (Section D)
APPLIED MEDICAL RESOURCES
22872 avenida empresa
rancho santa margarita CA 92688
Manufacturer Contact
22872 avenida empresa
rancho santa margarita, CA 92688
9497138059
MDR Report Key7503570
MDR Text Key108483767
Report Number2027111-2018-00168
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK041795
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/29/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/10/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device MODEL NumberCTF03
Device Catalogue Number101138401
Device LOT Number1311487
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/25/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/01/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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