MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTF01, 5X150 KII FIOS ZTHR 6/BX; GCJ

Model Number	2
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/08/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: the event unit was returned to applied medical for evaluation.The septum, an internal rubber component of the obturator, was askew.Engineering attempted to replicate the complainant's experience, but was unable to and the unit function as intended.The likely root cause of complainant's experience is due to the scope, while twisting and turning, catching on the rubber components inside the obturator.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.
Event or Problem Description
Procedure performed unknown - "did not allow 5 mm scope to pass through obturator".Patient status: "no patient harm".

• Brand Name: CTF01, 5X150 KII FIOS ZTHR 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6474303
• Report Number: 2027111-2017-01679
• Device Sequence Number: 13536310
• Product Code: GCJ
• UDI-Device Identifier: 00607915124014
• UDI-Public: (01)00607915124014(17)181013(30)01(10)1257158
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: 2
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/07/2017

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: Other
• Device Expiration Date: 10/13/2018
• Device Model Number: 2
• Device Catalogue Number: 2
• Device Lot Number: 1257158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2016
• Initial Report FDA Received Date: 04/07/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STRYKER 5 MM LAPAROSCOPE / SERIAL (B)(4)