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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTF73, 12X100 KII FIOS ZTHR 6/BX GCJ

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APPLIED MEDICAL RESOURCES CTF73, 12X100 KII FIOS ZTHR 6/BX GCJ Back to Search Results
Model Number CTF73
Device Problem Detachment of Device or Device Component (2907)
Patient Problems Internal Organ Perforation (1987); Blood Loss (2597)
Event Date 11/21/2018
Event Type  Injury  
Manufacturer Narrative

The event device is anticipated to return for evaluation. A follow-up report will be provided upon completion of the investigation.

 
Event Description

Procedure performed: ivor lewis esophagectomy. Event description: when dr. Inserted the trocar, the entire seal housing came off of the trocar. The surgeon lost insufflation and pulled out the trocar. The surgeon noted that the liver was pierced. It is unknown what intervention was provided. The surgeon used [non-applied] trocars to complete the case. The patient status is unknown. Additional information was received via email on (b)(4) 2018 from account manager: "i wanted to report an issue that dr. Had with an applied medical trocar in the operating room today. He was doing an ivor lewis esophagectomy and after initial insufflation he inserted the 12x100 mm trocar. The top of the trocar came off and dr. Lost insufflation. As a result of this malfunction there was injury to the patient. Dr. Stated "there was organ injury and bleeding. " we switched the trocar out to an [non-applied] trocar. Dr. Was able to control the bleeding and the surgery progressed. " additional information was received via email on (b)(4) 2018 from account manager: "the housing was easily removed from what i was told. No, the latch tabs did not break. Yes, the surgeon has used applied before in other surgeries with no problems. Not sure about the technique, i was not in the room and staff said they were not sure - he did it the same as always. No trouble inserting. Yes, they said he had a clear view. Patient status was stable; they completed the surgery no other problems".

 
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Brand NameCTF73, 12X100 KII FIOS ZTHR 6/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 Key8147838
MDR Text Key129832417
Report Number2027111-2018-00461
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 03/06/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/10/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCTF73
Device Catalogue Number101219101
Device LOT Number1336184
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/21/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/13/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/10/2018 Patient Sequence Number: 1
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