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

Model Number	CFR03
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/15/2018
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 balloon damage, which could have occurred when the retention ring was removed from the cannula.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 event is not reportable as it is unlikely to cause or contribute to death or serious injury.This report is to follow up medwatch report # mw5077984.This report represents the initial and final report.
Event or Problem Description
Procedure performed: unknown.Event description: the balloon failed to inflate.It is unknown if there was any patient contact.Limited information is available at this time.The patient status is unknown.It is unknown if the balloon was tested prior to placing the trocar into the patient.It is unknown if any instruments came into contact with the balloon.The device is with the risk management department at the hospital at this time.The lot number is unknown at this time.Additional information was received via email on 15may2018 from account manager: "balloon never inflated" "no damage and no retractors" additional information was received via email on 20jun2018 from account manager: "after speaking with the account, the balloon on the cfr03 was damaged due to the scrub tech pulling the retention ring off the cannula.Due to error of their employee, they are not requesting a return on the product." additional information received via medwatch #mw5077984 on 9jul2018: "failed to inflate" additional information received via mail from risk management department 16jul2018: "yes, i believe these are from the same incident report.I have it in my possession if you need to see it." patient status: unknown.

• 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: 7699808
• Report Number: 2027111-2018-00233
• Device Sequence Number: 1040096
• Product Code: GCJ
• UDI-Device Identifier: 00607915119881
• UDI-Public: (01)00607915119881(17)201227(30)01(10)1312970
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K083638
• 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): 07/18/2018

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: 12/27/2020
• Device Model Number: CFR03
• Device Catalogue Number: 101221201
• Device Lot Number: 1312970
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2018
• Initial Report FDA Received Date: 07/18/2018
• Patient Sequence Number: 1