• 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 10
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/19/2017
Event Type  malfunction  
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. 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.
 
Manufacturer Narrative
The event device is anticipated to return. A follow-up report will be provided upon completion of investigation. There is no report of serious injury or death associated with this event.
 
Event Description
Transanal mass incision - the seal from the gelpoint trocar sleeve was dislodged towards the end of the case. A storz needle driver and vlock suture were used within the sleeve. It was stated that the instruments were passed through the sleeve no more than 10 times and the manipulation of the instruments were not considered aggressive. The surgeon was able to retrieve the piece with no patient injury. Type of intervention - na. Patient status - no patient injury.
 
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 Key6544520
MDR Text Key192678063
Report Number2027111-2017-01764
Device Sequence Number1
Product Code FER
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
10
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
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 Received05/04/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date09/02/2018
Device Model Number10
Device Catalogue Number10
Device Lot Number1253551
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/02/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/19/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2015
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: 05/04/2017 Patient Sequence Number: 1
Treatment
STORZ NEEDLE DRIVER, VLOCK SUTURE
-
-