MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES A0G02, SZ 2 INSERT STEALTH FIBRA 10/BX; DXC

Model Number	11
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/30/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was returned for evaluation.Upon inspection, engineering found damage to a tab of the insert and was able to confirm the customer experience.The root cause could not be determined.Since all units undergo 100% inspection at top level, it is most likely that the root cause is user error.The instructions for use state "to place an insert, slide the tip of the clamp into the closed end of the insert.Press the insert onto the clamp by applying pressure at the tip and sliding the thumb across the insert towards the proximal end." an improper insertion method could result in the tab damage observed.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 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 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
Before procedure - "please see the report (b)(4) with pictures." event description: "(on (b)(6) 2016) during a check prior to use, a medical staff tried to attach the insert to a clamp made by applied medical.Unfortunately one of the plastic base stopper tip was broken and it failed to be attached to clamp.At the hospital, the same event (plastic tip breakage) was occurred twice within the past 7 days before making this report.This event didn't affect the patient.Please investigate the possible root cause." comments from (b)(6): - "one (1) unit of insert was returned from the customer.We confirmed the device and found that one of the plastic base tip was broken.The product will be returned to applied medical.Please investigate the possible root cause." patient status: "no health damage has been reported with the patient.".

• Brand Name: A0G02, SZ 2 INSERT STEALTH FIBRA 10/BX
• Common Device Name: DXC
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6382268
• Report Number: 2027111-2017-01506
• Device Sequence Number: 13563503
• Product Code: DXC
• UDI-Device Identifier: 00607915114732
• UDI-Public: (01)00607915114732(17)200211(30)01(10)1251660
• Combination Product (Y/N): N
• PMA/510(K) Number: 11
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/06/2017

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: 02/11/2020
• Device Model Number: 11
• Device Catalogue Number: 11
• Device Lot Number: 1251660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2016
• Initial Report FDA Received Date: 03/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1