• 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 CNO12, GELPOINT PATH 9CM FER

  • 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 CNO12, GELPOINT PATH 9CM FER Back to Search Results
Model Number CNO11
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/13/2016
Event Type  malfunction  
Manufacturer Narrative
The incident device is anticipated to return. A follow-up report will be provided upon completion of investigation. In accordance to 21 cfr 803. 56, if we obtain additional information, which was not known or was not available when the initial report was submitted, then the supplemental report will be submitted to the fda. There is no report of serious injury or death associated with this event.
 
Event Description
On tamis procedure - "inner lumen of gelpoint path trocar dislodged - surgeon did not removed from patient immediately and proceeded with case. Surgeon suggested this may have resulted from the diathermy tip, as the instrument was brand new. The surgeon completed multiple exchanges and it is thought he stabbed inner lumen with the diathermy tip and dragged internals of the trocar through. Photo's to be emailed separately. " patient status - no patient injury.
 
Manufacturer Narrative
The event unit was returned to applied medical for evaluation. Upon investigation, engineering confirmed that the shield, an internal component of the seal, had dislodged from one of the trocar sleeves. The shield was visually inspected and scratches and marks were observed on the dislodged shield. It is likely that the trocar shield was dislodged by an instrument that was used during the procedure. Based on the damage that was observed on the dislodged shield, it is likely that an instrument caught on the shield during insertion and dislodged it from the trocar sleeve. The instructions for use (ifu) states that "extra care should be used when inserting angular and asymmetrical instruments, such as 'j' hooks and clip appliers", and "all instruments should be centered axially when inserted through the seal". 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCNO12, GELPOINT PATH 9CM
Type of DeviceFER
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 Key6223878
MDR Text Key63916353
Report Number2027111-2017-00006
Device Sequence Number1
Product Code FER
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K133393
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 12/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberCNO11
Device Catalogue Number101351501
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/31/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/13/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/04/2017 Patient Sequence Number: 1
Treatment
DIATHERMY TIP
-
-