MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8313, XXS ALEXIS WND PROT/RET 5/BX; KGW

Model Number	C8313
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned for evaluation but lot # is provided.A device history report is to be reviewed by engineering.A final report will be sent once the results have been analyzed.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 or Problem Description
Vats.Lobectomy - at the end of mr kirks case when removing the xxs alexis a small tear was evident near to the green deployment ring.The sample was not retained however it was pulled from the same lot (1274511) as subsequent cer on (b)(6) 2017.Additional information received via email from applied medical team member, february 8, 2017: all surgeons have been using alexis regularly (xs & xxs) since last quarter.Additional instruments used (not a definitive list but most commonly): diathermy (hook), stapler (covidien/ethicon), hem-o-lok and various instruments from there set including forceps, scissors, grasper & clamps).[surgeon] commented that it may have been possible that he had caught the sheath with his hook diathermy.Patient status - no patient injury or illness associated with the event.Additional information received via email from applied medical team member, february 8, 2017: "all fine.No patient illness or injury occurred in any of the cases.".
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.In the absence of the subject device, it is difficult to determine the root cause of the event.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.

• Brand Name: C8313, XXS ALEXIS WND PROT/RET 5/BX
• Common Device Name: KGW
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6363282
• Report Number: 2027111-2017-01465
• Device Sequence Number: 18841833
• Product Code: KGW
• UDI-Device Identifier: 00607915118129
• UDI-Public: (01)00607915118129(17)190708(30)01(10)1274511
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K041711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2017

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: Other
• Device Expiration Date: 07/08/2019
• Device Model Number: C8313
• Device Catalogue Number: 101355501
• Device Lot Number: 1274511
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/27/2017
• Supplement Report FDA Received Date: 04/22/2017
• Patient Sequence Number: 1