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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTB14, KII 5X55 KII SH BLD ZTHR DP 10/BX GCJ

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APPLIED MEDICAL RESOURCES CTB14, KII 5X55 KII SH BLD ZTHR DP 10/BX GCJ Back to Search Results
Model Number CTB14
Device Problem Mechanical Jam (2983)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/05/2017
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

Procedure performed: laparoscopic hernia repair. Event description: i was in attendance at the time of the following event. Applied medical are currently evaluating trocars in this hospital as part of aneurin bevan trust. The primary port was placed, by the surgeon mr [name]. Using internal vision controlled by mr [name], his registrar ms [name] attempted to place a secondary 5 mm port (ctb14). The initial 'click' was audible on entry which suggested the blade was engaged,. She proceeded to cut through abdominal tissue and the port came in to view. The blade was clearly visable. Ms [name] suggested she had heard the secondary 'click' but the blade had not retracted as it should have done. It was obvious that though not cutting any tissue was still exposed. Ms [name] removed the bladed obturator from the cannula and continued with the procedure. No injury to the patient was caused as a result of the exposed blade. The bladed obturator was collected following the procedure, and is being kept at the theatre managers office awaiting collection. Type of intervention: surgeon removed the bladed obturator from the cannula and continued with the procedure. Patient status: did a patient injury or illness occur associated with the complaint event? no. Patient recovering normally.

 
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Brand NameCTB14, KII 5X55 KII SH BLD ZTHR 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 Key6909019
MDR Text Key88253338
Report Number2027111-2017-02007
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeGB
PMA/PMN NumberK072674
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/21/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/02/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device EXPIRATION Date05/03/2020
Device MODEL NumberCTB14
Device Catalogue Number101065801
Device LOT Number1296337
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/26/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/05/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/01/2017
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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