MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTS22, 12X100 KII Z-THR SLV, 12/BX; GCJ

Model Number CTS22

Device Problem Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The event device has been returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.

Event Description

Procedure performed: ni.Event description: "this is a complaint from the market.Administrative no.(b)(4).Please refer to the complaint sheet for investigation.Uncomfortable about resistance difference between firstly and subsequently inserting an instrument into trocar.Report from the sales rep: the customer felt resistance in firstly inserting a forceps into the trocar.During subsequently inserting it into the trocar, he was able to use the trocar without any problems.The surgery was successfully completed using this trocar.Any material fragmentations didn't occur.No patient injury.Request: the customer would like to know why he felt resistance in firstly inserting a forceps into the trocar and why feeling resistance wasn't replicated during subsequently inserting a forceps into the trocar.Please include the answer to these questions into closing letter.Initial investigation report: the event unit was returned to us and visually inspected.The septum was torn and not fragmented.The unit will be returned to amr for further evaluation.Admin# (b)(4)".Type of intervention: "the surgery was successfully completed using this trocar".Patient status: "no patient injury".

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.The complainant's experience of resistance during instrument insertion could not be replicated.The septum, an internal rubber component of the seal, was found to be torn.The shield, a clear plastic component of the seal, was observed to be dislodged.Based on the condition of the returned unit and the description of the event, it is likely that the torn septum and dislodged shield were caused by an instrument.Applied medical's instructions for use states that, "extra care should be used when inserting angular and asymmetrical instruments, such as 'j' hooks and clip appliers.All instruments should be centered axially when inserted through the seal to prevent tearing." 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: CTS22, 12X100 KII Z-THR SLV, 12/BX
• Type of Device: GCJ
• 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: 7125683
• MDR Text Key: 96029967
• Report Number: 2027111-2017-02156
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: K060096
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CTS22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/22/2017
• 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