MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFF73, 12X100 KII FIOS ADVFIX 6/BX; GCJ

Model Number CFF73

Device Problems Difficult to Insert (1316); Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/24/2016

Event Type  malfunction  

Manufacturer Narrative

Ra has received the incident device and the product has been assigned to engineering for evaluation.A follow-up report will be sent 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.There is no report of serious injury or death associated with this event.

Event Description

Laparoscopic gastric sleeve - "when torquing the trocars instruments would become hung up in the cannula.Doctor said it feels "sticky" when moving instruments through the ports." patient status: "patient is fine." additional information received via email june 8, 2016: "the instruments that were being used through the ports were a 10mm camera and hunter graspers.Drag was noticed immediately once ports began being used in the early stages of the procedure.After trouble shooting with the doctor, he made the decision to remove the ports shortly after due to the drag persisting.".

Manufacturer Narrative

Investigation summary: the event unit was returned for evaluation.Engineering visually inspected the seal and found no damage to the seal or its components.Engineering attempted to replicate the customer's experience using the returned obturator, but the customer's experience could not be replicated.During the manufacturing process, all seals are thoroughly inspected for functionality and performance prior to packaging.The root cause of the event is likely due to instruments getting caught on the septum components of the seal during insertion / removal.Although the exact root cause could not be confirmed, 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 on june 7, 2016 from applied team member: the instruments that were being used through the ports were a 10mm camera and hunter graspers.Drag was noticed immediately once ports began being used in the early stages of the procedure.After troubleshooting with the doctor, he made the decision to remove the ports shortly after due to the drag persisting.

• Brand Name: CFF73, 12X100 KII FIOS ADVFIX 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: 5740298
• MDR Text Key: 47893787
• Report Number: 2027111-2016-00458
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915117658
• UDI-Public: (01)00607915117658(17)190321(30)01(10)1266840
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083638
• 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: 12/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/21/2019
• Device Model Number: CFF73
• Device Catalogue Number: 101245501
• Device Lot Number: 1266840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2016
• 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