MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTR73 12X100 KII OPT ZTHR 6/BX; GCJ

Model Number CTR73

Device Problem Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/27/2016

Event Type  malfunction  

Manufacturer Narrative

The incident device is anticipated to return.A follow-up report will be provided upon completion of the investigation.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when the initial report was submitted, then the supplemental report will be submitted to the fda.There is no report of serious injury or death associated with this event.

Event Description

Procedure performed - unknown."this is a complaint from the market.(b)(4).Please refer to the complaint sheet for investigation.Report from the sales rep - the customer felt strong resistance when inserting a stapler 'echelon' made by ethicon through this event product.He/she needed more strong power than as usual in inserting the device.He/she has never experienced this incident since becoming a (b)(4) customer.The sales rep had difficulty in asking the model number of the stapler to make sure if the diameter was acceptable.Initial investigation report by (b)(4) - the event unit was returned to olympus and visually inspected.It confirmed that we felt more resistance than some seals of the same trocar model, when inserting a bar with the diameter size approx.1cm, as the customer mentioned.The septum was found to be torn indicated by a red arrow in the left picture.Very small multiple scratches were present on the mouth of the cannula below in the right picture.Other than those, no visible damage and no foreign material were found with the double duck bill and shield.The unit will be returned to amr for further evaluation.(b)(4).Requests: the customer would like to know the following point.Please include answers to this question in the closing letter.1 to investigate if the event septum and shield had appropriate flexibility, compared to conforming products." patient status - "no patient injury".

Manufacturer Narrative

Investigation summary: the event unit was returned for evaluation.Upon inspection, engineering noted no visible damage to the exterior, duckbill, shield, or seal housing.The duckbill was removed and it was confirmed that the septum was torn.Engineering could not confirm the customer's experience of "strong resistance." the tear in the septum may have decreased resistance during testing; however, grease that would have prevented abnormal resistance was also found to be present.The root cause of the drag force is unknown because engineering was unable to replicate the customer's experience.The root cause of the septum tear was likely due to the protruding tabs of a stapler inserted in the trocar.All seals are thoroughly inspected and tested 100% for leakage during the manufacturing process.There is always a potential to tear or dislodge the internal seal components with multiple passes of instruments, especially with sharp or angular devices.The instructions for use (ifu) warns, "extra care should be used when inserting angular and asymmetrical instruments.All instruments should be centered axially when inserted through the seal to prevent tearing." applied medical has opened a corrective and preventative action (capa) to further elevate and track this investigation and implement appropriate corrective actions to mitigate this type of event.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 the supplemental report will be submitted to the fda.

• Brand Name: CTR73 12X100 KII OPT ZTHR 6/BX
• Type of Device: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138233
• MDR Report Key: 5844928
• MDR Text Key: 51122002
• Report Number: 2027111-2016-00557
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915123680
• UDI-Public: (01)00607915123680(17)181029(30)01(10)1258481
• Combination Product (y/n): N
• PMA/PMN Number: K060096
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/29/2018
• Device Model Number: CTR73
• Device Catalogue Number: 101291101
• Device Lot Number: 1258481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1