MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFR03, 5X100 KII OPT ADVFIX 6/BX; GCJ

Model Number	CFR03
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/11/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: the event product was returned to applied medical for evaluation.Upon inspection, engineering noted dislodgement of an internal rubber component of the seal.The likely root cause of the seal leakage is due to the dislodged rubber component, possibly resulting from instrument damage.As the instructions for use (ifu) states, "as with all trocars, instrument compatibility should be evaluated prior to use." 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 seal leakage during initial intake of the complaint, the event was not reportable as it was unlikely to cause or contribute to death or serious injury.After engineering performed their evaluation, the event is now reportable due to dislodgement of the internal component of the seal.
Event or Problem Description
Procedure performed unknown- "this is a complaint from the market.(b)(4).Please refer to the complaint sheet for investigation.Report from the sales rep: during a procedure, gradual air leakage occurred.There was no abrupt loss of pneumo and visibility.Initial investigation report by (b)(4): the event unit was returned to (b)(4) and visually inspected.The obturator remained inserted into the trocar.No damage was observed with the ddb, the septum and shield.No foreign material was found inside the stopcock lever.The ddb was in the state of being easily removed from the seal.It's unknown if the customer made this to check the septum or not.Olympus could not identify this caused the reported incident.The unit will be returned to amr for further evaluation.(b)(4)." patient status: "no patient injury".

• Brand Name: CFR03, 5X100 KII OPT ADVFIX 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6434179
• Report Number: 2027111-2017-01613
• Device Sequence Number: 10838479
• Product Code: GCJ
• UDI-Device Identifier: 00607915119881
• UDI-Public: (01)00607915119881(17)190609(30)01(10)1272662
• Combination Product (Y/N): N
• PMA/510(K) Number: K083638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/24/2017

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: Health Professional
• Device Expiration Date: 06/09/2019
• Device Model Number: CFR03
• Device Catalogue Number: 101288701
• Device Lot Number: 1272662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2016
• Initial Report FDA Received Date: 03/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1