MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8302, M ALEXIS WND PROT/RET 5/BX; KGW

Model Number	3
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/17/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was returned for evaluation.Upon inspection, engineering confirmed the customer experience.No warping or stress marks were found to indicate the tear was a result of surgical tool interaction.The root cause for the sheath tear is most likely due to a minute melt distortion.New equipment has increased stability of the manufacture process.All units receive inspection for non-conformances.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary.This report is being filed as a result of a re-review of applied medical complaints received between june 1, 2014 and may 31, 2016.This retrospective review was associated with a quality management system (qms) compliance action plan developed and presented to fda to address an april 10, 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 to 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
Laparoscopic anterior resection- "alexis retractor split as soon as it was deployed." patient status - unaffected.

• Brand Name: C8302, M 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: 6378853
• Report Number: 2027111-2017-01381
• Device Sequence Number: 18965037
• Product Code: KGW
• UDI-Device Identifier: 00607915117214
• UDI-Public: (01)00607915117214(17)170319(30)01(10)1218545
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: 3
• 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

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: 03/19/2017
• Device Model Number: 3
• Device Catalogue Number: 3
• Device Lot Number: 1218545
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2014
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2014
• Initial Report FDA Received Date: 03/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1