• 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 CTF03, 5X100 KII FIOS Z-THR 6/BX LAPAROSCOPE, GENERAL & PLASTIC SURGERY

  • 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 CTF03, 5X100 KII FIOS Z-THR 6/BX LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number CTF03
Device Problems Break (1069); Material Twisted/Bent (2981)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/03/2019
Event Type  Malfunction  
Manufacturer Narrative

The event unit was returned to applied medical for evaluation. Visual inspection confirmed the complainant¿s experience of a bent trocar. The obturator was also cracked and fractured. Based on the condition of the returned unit, it is likely that the bent cannula was caused by a high force that was applied to the trocar during insertion. It is possible that the obturator cracked and fractured due to a material abnormality or prolonged lipid exposure while the unit was in transit; however, the exact root cause could not be determined. The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level. A bent trocar is considered not reportable as it is unlikely to cause or contribute to death or serious injury. The event is being reported due to the fracture that was observed on the obturator during evaluation of the product.

 
Event Description

Procedure performed: laparoscopic right oophorectomy. Event description: limited information is available at the time of reporting. Per the cer form, "20 year old female patient, no prior surgery. Abdomen already insufflated, kii trocar bent during insertion. " additional information was received from applied medical implementation specialist, via e-mail on october 4th, 2019: "procedure performed was a laparoscopic right oophorectomy. First stick was a 12mm x 150mm ees optical trocar at the umbilicus. Abdomen was insufflated and a scope was placed through the 12mm ees trocar for direct visualization for the placement of a second trocar, the ctf03. The ctf03 bent under force of insertion. The bent ctf03 was replaced with a new ctf03 and the case was completed. " intervention: "bent ctf03 was replaced with a new ctf03 and the case was completed. " patient status: "patient is fine".

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCTF03, 5X100 KII FIOS Z-THR 6/BX
Type of DeviceLAPAROSCOPE, GENERAL & PLASTIC SURGERY
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 Key9537025
MDR Text Key177626203
Report Number2027111-2019-00678
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
Report Date 12/31/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/31/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCTF03
Device Catalogue Number101138401
Device LOT Number1364532
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/21/2019
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/19/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/09/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-