MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8502, M ALEXIS LAP SYS 6/BX; KGW

Model Number	C8502
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/13/2016
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 follow-up 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.
Event or Problem Description
Laparoscopic right hemi colectomy - "i was not present at the hospital or case.The surgeon was removing device from patient and noticed a tear in the alexis sheath.Surgeon is a regular user of alexis and advised scrub nurse that this was not caused by the surgeon.Main concern was that there may be material left in patient - after examination, surgeon happy this was not the case." patient status - "n/a".
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: C8502, M 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: 6223599
• Report Number: 2027111-2017-00005
• Device Sequence Number: 623554
• Product Code: KGW
• UDI-Device Identifier: 00607915119935
• UDI-Public: (01)00607915119935(17)190510(30)01(10)1270102
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K093296
• 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): 03/02/2017

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: 05/10/2019
• Device Model Number: C8502
• Device Catalogue Number: 101357101
• Device Lot Number: 1270102
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/04/2017
• Supplement Report FDA Received Date: 03/02/2017
• Patient Sequence Number: 1