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

Model Number	CTF71
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, testing was unable to be performed and the complainant's experience could not be replicated or confirmed.Based on the description of the event, it is likely that the reported event was caused by forces exerted on the unit during manipulation of the scope inside the trocar.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.This report represents the initial and final report.Based on the description of the event received, the event is deemed not reportable as it poses minimal risk to the patient and unlikely to cause or contribute to death or serious injury.This report is to follow up medwatch report (b)(4).
Event or Problem Description
Procedure performed: robotic hiatal hernia.Event description: "dr.[name] was performing a robotic hiatal hernia.At the beginning of the case, he inserted the ctf71 for his camera port, then inserted the scope to look around.At this point, there were no issues.Dr [name] removed the camera from the port and docked the robot.He then attempted to reinsert the scope, but it would not fully advance into the cannula.He gently pushed the scope into the trocar with no advancement, and at that point, the staff noticed that the cannula was slightly bent.Dr.[name] removed the scope from the cannula and removed the bent cannula.At that point, the staff noticed that the lense of the scope was crackled and hazy, and that the scope needed to be replaced.Dr.[name] inserted a new ctf71 and used a different scope with the new trocar.The new trocar and scope did not present any difficulties." additional information received via email from the territory manger on 12-june-2017."as for the event sample, the staff asked for it to be saved and cleaned, but spd discarded it".Received medwatch form from fda under report (b)(4) via mail on 06-oct-2017: "a 12 x 150 mm applied medical access port was used in the usual fashion for abdominal access during a robotic surgery.While changing the robotic scope angle from 30 up to 30 down, it was found that the access port had a bend in it which would not allow for reinsertion of the robotic camera.The robotic camera was then found to have condensation inside which could possibly be related to trying to place camera back into a bent port.No fragments were found to be missing from the access port." additional information received via email from v.P.Quality, risk, and patient safety at (b)(6) hospital, on 06-oct-2017: original incident date reported as (b)(6) 2017.Medwatch form reported incident date as (b)(6) 2017.Per v.P.:: "according to the medical record it was the (b)(6)." patient status: no patient injury or no illness occurred.

• Brand Name: CTF71, KII FIOS 12X150MM Z-THREAD, 6BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6945396
• Report Number: 2027111-2017-02059
• Device Sequence Number: 10933603
• Product Code: GCJ
• UDI-Device Identifier: 00607915125035
• UDI-Public: (01)00607915125035(17)200224(30)01(10)1289881
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K041795
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 02/24/2020
• Device Model Number: CTF71
• Device Catalogue Number: 101470688
• Device Lot Number: 1289881
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2017
• Initial Report FDA Received Date: 10/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79