MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8312, XS ALEXIS WND PROT/RET 5/BX; KGW

Model Number	C8312
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to return.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: cs - "the surgeon inserts the green ring to patient body, and then they starting to curl the white ring with wound sheath.Suddenly, the wound sheath just came apart near green ring." type of intervention: no injury or illness occurred associated with the complaint event.Patient status: "fine".
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Upon visual inspection, engineering confirmed that there was a tear originating from a puncture in the sheath.Based on the condition of the returned unit, it is likely that the reported event was caused by instruments that were used during the procedure.Engineering determined that the sheath was pierced when the suture was placed and the hole propagated when force was applied to the device during retraction.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.
Event or Problem Description
Additional information received via email from distributor, 26jun2017: no other instruments or retractors were being used prior to alexis placement.But, the customer sews up a suture on the green ring (image provided).No other instruments or retractors were being used during alexis placement.

• Brand Name: C8312, XS 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: 6664655
• Report Number: 2027111-2017-01865
• Device Sequence Number: 18843612
• Product Code: KGW
• UDI-Device Identifier: 00607915117245
• UDI-Public: (01)00607915117245(17)200313(30)01(10)1292166
• 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): 09/05/2017

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: 03/13/2020
• Device Model Number: C8312
• Device Catalogue Number: 101355601
• Device Lot Number: 1292166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2017
• Supplement Date Received by Manufacturer: 06/13/2017
• Initial Report FDA Received Date: 06/23/2017
• Supplement Report FDA Received Date: 09/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1