MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C0R37, 15X100MM KII Z-THR OPT SYS, 6/BX; GCJ

Model Number	11
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/10/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event product was returned to applied medical for evaluation.Upon inspection, engineering noted no damage to the seal or its internal components.The device met current specifications.The root cause is most likely the seamguards increasing the size of the stapler and creating additional resistance.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.This report is being filed as a result of a re-review of applied medical complaints received between (b)(6) 2014 and (b)(6) 2016.This retrospective review was associated with a quality management system (qms) compliance action plan developed and presented to fda to address an (b)(6) 2015 warning letter.Applied medical has revised its mdr reporting criteria to be more conservative and has improved complaint handling and mdr reporting processes.The reviews ensured that recent reportable events were appropriately identified and reported to the designated regulatory authority(ies).This report, which represents the initial and final reports combined, is being submitted based on the findings of that retrospective review.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.
Event or Problem Description
"dr wanted to trial 15x100mm port.Dr put two seamguards on the stapler and it wouldn't go down the port.It did however go down the xcel 15mm port." patient status: unknown.

• Brand Name: C0R37, 15X100MM KII Z-THR OPT SYS, 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6370832
• Report Number: 2027111-2017-01173
• Device Sequence Number: 13645398
• Product Code: GCJ
• UDI-Device Identifier: 00607915116422
• UDI-Public: (01)00607915116422(17)180301(30)01(10)1241420
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: 11
• 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
• Report Date (Section B): 03/01/2017

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: Health Professional
• Device Expiration Date: 03/01/2018
• Device Model Number: 11
• Device Catalogue Number: 11
• Device Lot Number: 1241420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2015
• Initial Report FDA Received Date: 03/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ENDO GIA ULTRA 12MM EXTRA LARGE EGIAUXL(EGIA60AXT); GORE SEAMGUARD (1BSGTRI60B)