MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFS03, 5X75 KII SLEEVE ADVFIX 12/BX; GCJ

Model Number	6
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/23/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was returned for evaluation.Engineering was able to confirm the customer's experience of bent obturator.The root cause of the event is improper use.The obturator must be used with a compatibly sized cannula.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
Diagnostic laparoscopic + biopsy - "a 5x100mm obturator was inserted into a 5x75mm advanced fixation sleeve.Mr.(b)(6) used the trocar with the wrong obturator.The obturator was bent at the point which it came out of the cannula.Mr.(b)(6) had been passed the wrong length obturator.Product cfs03 is not available anymore for evaluation.However the hospital has returned by mistake the 3 following devices used in this procedure: 1 ea ctb73 batch 1245782, 1ea cts22 batch 1246103, 1ea cff73 batch 1245796.Rga60676923 has been updated with removal of cfs03 and addition of the above 3 products." patient status - fine.

• Brand Name: CFS03, 5X75 KII SLEEVE ADVFIX 12/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6370902
• Report Number: 2027111-2017-01200
• Device Sequence Number: 19102951
• Product Code: GCJ
• UDI-Device Identifier: 00607915123130
• UDI-Public: (01)00607915123130(17)180514(30)01(10)1246629
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: 6
• 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: 05/14/2018
• Device Model Number: 6
• Device Catalogue Number: 6
• Device Lot Number: 1246629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2015
• 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: CTB73, CTS22, CFF73