MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTR03, 5X100 KII OPT ZTHR 6/BX; GCJ

Model Number	CTR03
Medical Device Problem Codes	Material Fragmentation (1261); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/17/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: the event unit was returned for evaluation.Upon inspection, engineering confirmed that the tip of the cannula was melted.The root cause of the melted cannula could not be determined, but is likely that the cannula came into contact with a hot instrument.A review of the manufacturing records indicates this lot passed all manufacturing and quality inspections.  additionally, engineering found that the septum in the seal was torn.The root cause could not be determined, but is likely due to instruments catching on the septum.Per the 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." during the manufacturing process, all trocars are thoroughly inspected for functionality and performance prior to packaging.Although the exact root cause could not be determined, 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.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when this report was submitted, then a supplemental report will be submitted to the fda.This document represents our initial and final report.
Event or Problem Description
" this is a complaint from the market.(b)(4).Please refer to the complaint sheet for investigation." report from the sales rep: "the customer found the distal end of the cannula was melted.He/she was unfamiliar when the incident happened during a treatment." initial investigation report by (b)(6): "the event unit was returned to olympus and visually inspected.Upon visual inspection, the distal end of the cannula was found to be partially damaged like melted, however, not causing the cannula to be fractured.The septum was found to be torn and a piece of the septum (size: approximately 3.3mm x 4.9mm) was found inside the cannula by the side of the seal.Confirmed the piece was similar to the cut shape of the septum.The unit will be returned to amr for further evaluation.(b)(4)." requests: "the customer acknowledged that the incident didn't happen due to an error in manufacturing process.However, he/she would like to know the following point.Please include answers to this question in the closing letter.What situations are considered to encounter those kinds of the incident the customer experienced?".

• Brand Name: CTR03, 5X100 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: 6068450
• Report Number: 2027111-2016-00745
• Device Sequence Number: 863892
• Product Code: GCJ
• UDI-Device Identifier: 00607915123482
• UDI-Public: (01)00607915123482(17)180708(30)01(10)1249967
• Combination Product (Y/N): N
• 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): 06/16/2016

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: 07/08/2018
• Device Model Number: CTR03
• Device Catalogue Number: 101290101
• Device Lot Number: 1249967
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2016
• Initial Report FDA Received Date: 10/31/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1