MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8501, S ALEXIS LAP SYS 6/BX; KGW

Model Number	C8501
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/29/2017
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
Lap.Proximal gastrectomy - "sheath was torn during the surgery".Type of intervention: unknown.Patient status: no patient injury or related illness.
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 the reported event was caused by the instrumentation used during the procedure.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: C8501, S ALEXIS LAP SYS 6/BX
• Common Device Name: KGW
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6664697
• Report Number: 2027111-2017-01866
• Device Sequence Number: 44249
• Product Code: KGW
• UDI-Device Identifier: 00607915119928
• UDI-Public: (01)00607915119928(17)190929(30)01(10)1280459
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K093296
• 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: 09/29/2019
• Device Model Number: C8501
• Device Catalogue Number: 101357001
• Device Lot Number: 1280459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2017
• 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