MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8301, S ALEXIS WND PROT/RET 5/BX; KGW

Model Number	C8301
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/04/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident device is anticipated to return.A follow-up report will be provided upon completion of the investigation.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 associtated with this event.
Event or Problem Description
Procedure performed lar - "they insert green ring to patient body and then find the sheath was broken." patient status - fine.Type of intervention - na.
Additional Manufacturer Narrative
Additional information was requested from the customer and was not provided.Investigation summary: the event product was returned for evaluation.Upon inspection, engineering confirmed the sheath was torn.Engineering also noticed marks on the device caused by strain.A review of the manufacturing records indicated this lot passed all manufacturing and quality inspections.All alexis devices undergo 100% visual and functional inspection during the manufacturing and assembly process.Although the exact root cause of the event could not be confirmed, the root cause is likely use error; the initial tear was most likely caused by a dissector.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 the supplemental report will be submitted to the fda.

• Brand Name: C8301, S 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: 5948390
• Report Number: 2027111-2016-00632
• Device Sequence Number: 915660
• Product Code: KGW
• UDI-Device Identifier: 00607915117207
• UDI-Public: (01)00607915117207(17)190421(30)01(10)1268104
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K041711
• 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,Followup
• Report Date (Section B): 12/13/2016

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: 04/21/2019
• Device Model Number: C8301
• Device Catalogue Number: 100726601
• Device Lot Number: 1268104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/14/2016
• Supplement Report FDA Received Date: 12/13/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1