MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CNO12, GELPOINT PATH 9CM; FER

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.

• Brand Name: CNO12, GELPOINT PATH 9CM
• Type of Device: FER
• 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 Key: 6223878
• MDR Text Key: 63916353
• Report Number: 2027111-2017-00006
• Device Sequence Number: 1
• Product Code: FER
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K133393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• 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 Received: 01/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CNO11
• Device Catalogue Number: 101351501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/13/2016
• 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 Sequence Number: 1
• Treatment: DIATHERMY TIP