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

Model Number CTF03

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Date 03/28/2017

Event Type  Injury  

Manufacturer Narrative

No product is being returned for evaluation but lot # is provided.A follow-up report will be provided upon completion of investigation.

Event Description

Diagnostic lap."attending surgeon dr.[doctor's name] was performing a diagnostic laparoscopy.During abdominal entry, item number (b)(4) was used as an optical first entry into an insufflated abdomen.Gas was placed on a low flow setting.The trocar was place inside the incision with counter traction using two towel clamps.Under direct visualization, downward pressure was applied with a twisting motion in order to advance the trocar through the abdominal layers.Upon entering the abdomen, an unintentional perforation occured to the stomach.The perforation was sutured closed during the case." additional information received via email from sales representative on march 29, 2017: "the patient was sent home same day per the physician.Product will not be returning, it was disposed of." type of intervention: "the perforation was sutured closed during the case." patient status: the patient was sent home same day per the physician.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.In the absence of the subject device, it is difficult to determine the root cause of the event.Based on the description of the event, the complainant did not allege any malfunction relating to the event unit.It was noted that this was the surgeon's first time using applied's fios® trocars, so the event could be attributed to user technique during insertion.As stated in the instructions for use (ifu), "potential complications associated with the use of fios first entry are the same as those associated with the use of surgical trocars, insufflation needles, and laparoscopic surgery in general and include, but are not limited to: superficial lesions, injury to internal vessels, bleeding, hematoma, injury to the abdominal wall, infection, peritonitis, and pre-peritoneal insufflation." 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.

Event Description

Additional information received via email from clinical development team member on may 19, 2017: "for this case, it was the surgeon's first time performing the fios technique as his first trocar entry.The error involving patient injury was more on the user's experience and there was no malfunction or defect to the product.The surgeon identified the perforation to the stomach at the end of the case and sutured the perforation closed during the case.The patient's status was fine and returned home that same day.The surgeon was able to perform a few other cases afterwards with the fios technique and they went just fine as he became more comfortable with the technique thereafter." additional information received via email from sales representative on may 19, 2017: "the perforation to the stomach was identified after all the trocars were placed in the patient and then sutured closed toward the end of the case.".

• 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: jennifer scoullar ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497133904
• MDR Report Key: 6458448
• MDR Text Key: 71683151
• Report Number: 2027111-2017-01677
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915123550
• UDI-Public: (01)00607915123550(17)200118(30)01(10)1287344
• 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: 06/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 01/18/2020
• Device Model Number: CTF03
• Device Catalogue Number: 101138401
• Device Lot Number: 1287344
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention