MAUDE Adverse Event Report: APPLIED MEDICAL CTF73, 12X100 KII FIOS ZTHR 6/BX; GCJ

Model Number CTF73

Device Problems Component Falling (1105); Material Deformation (2976)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 07/02/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The incident device is anticipated to return.A follow-up report will be provided upon completion of the 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.

Event Description

Robotic radical prostatectomy - "during robotic radical prostatectomy, robotic optic was re-inserted in trocar but it didn't slide well.For a better checking, trocar was removed and inspected.Inspection showed a damge in inner seal (universal seal): it was broken in 2 parts, one remained in the seal; the other fell down in abdomen and they had to search for it.Part of rubbers seal was damaged too, it seemed like deformed by melting due to overheating.(b)(6).Event sample is available for inspection.They don't want to use our trocar anymore and ask credit for remaining ones they have.They collected remaining sterile samples, they ask our collaboration to inspect them as soon as possible." type of intervention - "they searched for lost part of seal in abdomen and this takes some time." patient status - good.

Manufacturer Narrative

Adverse event/and or product problem was updated include adverse event.Additional information was requested from the customer and provided.Investigation summary: the event unit was returned for evaluation along with a rubber fragment.Upon inspection, engineering noted a dent in the midsection of the cannula and confirmed the customer's experience of septum fragmentation.However, no melting or heat damage was observed by engineering.Review of the validated list of trocars for the da vinci robot by intuitive shows that the ctf73, kii fios with z-thread cannula, is not validated.Using a non-validated cannula can lead to misalignment of the cannula respective to the robotic mount, which can result in non-axial instrument insertion.As stated in the instructions for use (ifu), "all instruments should be centered axially when inserted through the seal to prevent tearing." during the manufacturing process, all trocars are thoroughly inspected for functionality and performance prior to packaging.The root cause of the event is likely the result of using a non-validated trocar with the da vinci robot.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.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.

Event Description

Additional information received via email from team member on december 18, 2015: the da vinci robot was used for this surgery.A standard robotic optic (8 mm) was used in the procedure.There were no other instruments used within the trocar.The customer does not know what component/instrument/robotic part was overheating.The customer reported it, but there was no verification if the optic was overheating.

• Brand Name: CTF73, 12X100 KII FIOS ZTHR 6/BX
• Type of Device: GCJ
• Manufacturer (Section D): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138233
• MDR Report Key: 5262789
• MDR Text Key: 32771274
• Report Number: 2027111-2015-00848
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K041795
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/26/2018
• Device Model Number: CTF73
• Device Catalogue Number: 101219101
• Device Lot Number: 1240939
• Other Device ID Number: 00607915123703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2015
• 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): Required Intervention