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

Model Number	C8313
Medical Device Problem Codes	Material Fragmentation (1261); Material Perforation (2205)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned for evaluation, but a 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.
Event or Problem Description
Procedure performed: unk.(b)(4) received via maude database: (b)(4).Event description: "when removing a portion of the stomach via the port site, the alexis wound protector broke.A portion of the wound protector was in the abdomen.The surgeon removed the complete broken portion that was in the abdomen.X-ray was obtained.X-ray was negative." type of intervention: "the surgeon removed the complete broken portion that was in the abdomen." patient status: unk.
Additional Manufacturer Narrative
Investigation summary: 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: 7335029
• Report Number: 2027111-2018-00103
• Device Sequence Number: 13572758
• Product Code: KGW
• UDI-Device Identifier: 00607915118129
• UDI-Public: (01)00607915118129(17)200920(30)01(10)1306143
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K041711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2018

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: Other
• Device Expiration Date: 09/20/2020
• Device Model Number: C8313
• Device Catalogue Number: 101355501
• Device Lot Number: 1306143
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2018
• Supplement Date Received by Manufacturer: 02/12/2018
• Initial Report FDA Received Date: 03/13/2018
• Supplement Report FDA Received Date: 03/19/2018
• Patient Sequence Number: 1