MAUDE Adverse Event Report: APPLIED MEDICAL CTF71, KII FIOS 12X150MM Z-THREAD, 6/BX; GCJ

Model Number CTF71

Device Problem Use of Device Problem (1670)

Patient Problems Perforation of Vessels (2135); Injury (2348)

Event Date 03/24/2015

Event Type  Injury  

Event Description

Planned/scheduled da vinci robotic hysterectomy- "(b)(6), scrub tech, informed (b)(4) that dr.(b)(6) injured the patient's vena cava bifurcation during insertion of a laparoscopic camera trocar.(b)(4) spoke to the surgeon directly and was informed that the da vinci surgical system did not cause or contribute to the patient's injury.According to (b)(4), the insertion of the trocar was performed blindly and without direct visualization.Two cardiovascular surgeons repaired the vessel and the patient was closed and taken to the icu." intervention - "vessel repair." patient status - "stable.".

Manufacturer Narrative

No product is being returned for evaluation and no lot # has been provided to manufacturer.A final report will be sent once the results have been analyzed.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.

Manufacturer Narrative

The event product was not returned for evaluation.It was stated during complaint intake that this unit was not available for investigation.In the absence of the subject device, it is difficult to determine the root cause of the event.The root cause of the event could not be determined as the device was not returned to applied medical for investigation.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." during the manufacturing process, all trocars are thoroughly inspected for functionality and performance prior to packaging.Applied medical continuously seeks to improve the form, function and ease of use of its products and will continue to monitor its vigilance system for trends and take appropriate actions as necessary.In accordance with 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.

• Brand Name: CTF71, KII FIOS 12X150MM Z-THREAD, 6/BX
• Type of Device: GCJ
• Manufacturer (Section D): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer (Section G): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138233
• MDR Report Key: 4725440
• MDR Text Key: 18545808
• Report Number: 2027111-2015-00219
• 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: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: CTF71
• Device Catalogue Number: 101061801
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 11/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other; Required Intervention