MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C0R83, 12X60 KII OPT ZTHR 6/BX; GCJ

Model Number	C0R83
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/15/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: the event product was returned for evaluation.Upon inspection, engineering noted a missing portion on the septum.During the manufacturing process, all trocars are thoroughly inspected for functionality and performance prior to packaging.The root cause of the event is likely due to instruments.As stated in the instructions for use (ifu), "extra care should be used when inserting angular and asymmetrical instruments, such as 'j' hooks and clip appliers.All instruments should be centered axially when inserted through the seal to prevent tearing." although the exact root cause could not be confirmed, applied medical has opened a corrective and preventative action (capa) to further elevate and track this investigation and implement appropriate corrective actions to mitigate this type of event.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 a supplemental report will be submitted to the fda.This report represents the initial and final report.Based on the description of air leakage during initial intake of the complaint, the event was not reported as it was unlikely to cause or contribute to death or serious injury.After engineering performed their evaluation, the event is now deemed reportable.
Event or Problem Description
Gastrectomy - "client set up this device into patient body and then it is air leak." additional information received via email from distributor on september 7, 2016 the user does not know which instruments were introduced.There was an instrument at the time of leakage, but when they exchange the other c0r83 that is normal.The incision site was not larger than normal.Patient status: "fine".

• Brand Name: C0R83, 12X60 KII OPT ZTHR 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6237370
• Report Number: 2027111-2016-00923
• Device Sequence Number: 998243
• Product Code: GCJ
• UDI-Device Identifier: 00607915116668
• UDI-Public: (01)00607915116668(17)180428(30)01(10)1245060
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K060096
• 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
• Report Date (Section B): 01/10/2017

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: 04/28/2018
• Device Model Number: C0R83
• Device Catalogue Number: 101218501
• Device Lot Number: 1245060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2016
• Initial Report FDA Received Date: 01/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1