• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTB12, 5X100 KII SH BLD ZTHR DP 10/BX GCJ

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

APPLIED MEDICAL RESOURCES CTB12, 5X100 KII SH BLD ZTHR DP 10/BX GCJ Back to Search Results
Model Number CTB12
Device Problem Mechanical Jam (2983)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/10/2016
Event Type  Malfunction  
Manufacturer Narrative

The event unit was not returned to applied medical for evaluation. As the event unit was not returned, testing was unable to be performed and the complainant's experience could not be replicated or confirmed. Based on the additional information received, it is likely that the reported event was caused by a malfunction of the switch component. However, in the absence of the event unit, it is difficult to determine the exact root cause of the event. The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level. Applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products based on the description of the event during initial intake of the complaint, the event was not reportable as it was unlikely to cause or contribute to death or serious injury. After additional information was received, the event is now reportable. This report represents the combined initial and final.

 
Event Description

Procedure performed: laparoscopy event description: the trocar spike of 5 mm, defect = impossible to trigger the issue of the knife, the cursor does not hold. Clinical consequences: entry into force. Original: la pique du trocard de 5 mm, défaut = impossible d'enclencher l'issue du couteau, le curseur ne tient pas. Conséquences cliniques : entrée en force. Additional information received via email from sales representative on 15aug2017: additional questions were asked to the or-team, but it's a very old case and nobody seems to be able to answer the questions. Additional information received via email from sales representative on 21aug2017: blade forcefully exposed during the force introduction of the trocar because the cursor did not remain engaged. No piece fall into the patient. The non-conformance was identified at the beginning of the procedure. Risk taking since there is no safety of retraction of the blade type of intervention: unknown. Patient status: unknown.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCTB12, 5X100 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 Key6877798
MDR Text Key86792156
Report Number2027111-2017-02003
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeFR
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
Report Date 09/19/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/19/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/13/2019
Device MODEL NumberCTB12
Device Catalogue Number101413701
Device LOT Number1273892
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/03/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/01/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-