MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFR33, 11X100 KII OPT ADVFIX 6/BX; GCJ

Model Number	CFR33
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/06/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: the event unit was returned for evaluation.Upon inspection, engineering found a small scratch on the trocar and a crack from the tip of the cannula onto the balloon tubing.Engineering leak tested the balloon, but it would not retain air due to the crack on the cannula.The root cause of the crack is likely the result of excess external force applied on the cannula in combination with lipid exposure.During the manufacturing process, all trocars are 100% visually inspected and leak tested prior to packaging.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.This report represents the initial and final report.Based on the description of not being able to inflate the device during initial intake of the complaint, the event was not reported as it is unlikely to cause or contribute to death or serious injury.After engineering's evaluation, the event was deemed reportable as there is potential for death or serious injury due to the crack in the cannula.
Event or Problem Description
Myomectomy - "this device cannot inflate." patient status: "fine".

• Brand Name: CFR33, 11X100 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: 6113807
• Report Number: 2027111-2016-00831
• Device Sequence Number: 13640225
• Product Code: GCJ
• UDI-Device Identifier: 00607915123222
• UDI-Public: (01)00607915123222(17)180629(30)01(10)1248823
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 07/21/2016

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: Other
• Device Expiration Date: 06/29/2018
• Device Model Number: CFR33
• Device Catalogue Number: 101245801
• Device Lot Number: 1248823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2016
• Initial Report FDA Received Date: 11/18/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1