MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTF03, 5X100 KII FIOS Z-THR 6/BX; GCJ

Model Number CTF03

Device Problem Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/18/2016

Event Type  malfunction  

Manufacturer Narrative

Full udi unknown since no lot number was provided.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

Procedure performed unknown."the scrub technician (keith) indicated that dr.(b)(6) was beginning the procedure and he placed the scope into the trocar.Once he did so it would not advance all the way through and it was noticed that part of the seal was impeding the scope from going through.The surgeon then called for a new trocar and proceeded with the procedure.There was no injury to the patient." additional information received from sales representative 22 july 2016, 9:37 am: "i requested the lot # today and the customer indicated they didn't have it.".

Manufacturer Narrative

We have tried to obtain the incident device for evaluation with no success as of 25oct2016.The event unit was not returned for evaluation.In the absence of the subject device it is difficult to determine the root cause of the incident.A review of the manufacturing records for this lot could not be performed as no lot number was provided.  during the manufacturing process, all trocars are thoroughly inspected and tested prior to packaging.Although the exact root cause of the incident could not be confirmed, applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary.In accordance to 21 cfr 803.56, if additional information is obtained which was not known or was not available when this report was submitted, then a supplemental report will be submitted to the fda.

Event Description

Additional information received via e-mail on november 17, 2016 - it was the rep's understanding that the scope was placed into the obturator that was in the cannula.Also, unfortunately i am not aware which brand of camera/ laparoscope was used.

• Brand Name: CTF03, 5X100 KII FIOS Z-THR 6/BX
• Type of Device: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138233
• MDR Report Key: 5887503
• MDR Text Key: 52499310
• Report Number: 2027111-2016-00593
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041795
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CTF03
• Device Catalogue Number: 101404901
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1