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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFF12, 5X100 KII FIOS ADVFIX DP 10/BX GCJ

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APPLIED MEDICAL RESOURCES CFF12, 5X100 KII FIOS ADVFIX DP 10/BX GCJ Back to Search Results
Model Number CFF12
Device Problem Physical Resistance (2578)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/12/2017
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: exploratory laparoscopy with pipac procedure (aerosolized pressurized intraperitoneal chemotherapy event description: when using the equipment, the sleeve of the trocar was seized, hindering the sliding of the instruments. This incident induces discomfort for the operator, a change of equipment resulting in an extension and extra cost of the intervention. Original: lors de l'utilisation du matériel, la chemise du trocard était grippée, gênant le coulissement des instruments. Cet incident induit un inconfort pour l'opérateur, un changement de matériel d'où un allongement et un surcout de l'intervention. Additional information received from the sales representative via email on 13 nov 2017: it was difficult to slide the instrument in and out of the trocar. The instruments did not stop at a certain depth into the trocar, they were not sliding well. Type of intervention: change of device. Patient status: no patient injury or illness occurred associated with the complaint event.

 
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Brand NameCFF12, 5X100 KII FIOS ADVFIX DP 10/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 Key7031242
MDR Text Key92988393
Report Number2027111-2017-02110
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberK083638
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/12/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/14/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device EXPIRATION Date03/06/2020
Device MODEL NumberCFF12
Device Catalogue Number101452601
Device LOT Number1291746
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/07/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/23/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/01/2017
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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