MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CY010, 5MMX35CM EPIX LAPA DISSECT, 10/BX; GEI

Model Number	CY010
Medical Device Problem Code	Failure To Adhere Or Bond (1031)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: the event unit was returned and was visually inspected for non-conformances.Upon visual inspection, engineering found that the jaws had a slight misalignment, which confirms the customer's experience.The root cause of the customer's experience regarding "dissector scissored at tip" is due to surgeon preference.During manufacturing of cy010 dissectors (per (b)(4)), the alignment of the jaws is to be inspected after the riveting process has been completed.If misalignment of the jaws is observed, the operator is to manually adjust the jaws to align them as best as possible.If the jaws remain severely misaligned after three attempts of adjustment, the unit is to be scrapped.As this unit appears to have only a very slight misalignment, it was acceptable to pass inspection during top-level assembly and is fit for use.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary.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 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.
Event or Problem Description
Unknown procedure - "dissector scissored at tip." type of intervention - na.Patient status - "released.".

• Brand Name: CY010, 5MMX35CM EPIX LAPA DISSECT, 10/BX
• Common Device Name: GEI
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6333831
• Report Number: 2027111-2017-01444
• Device Sequence Number: 1022092
• Product Code: GEI
• UDI-Device Identifier: 00607915126964
• UDI-Public: (01)00607915126964(17)170916(10)1231356
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K103282
• 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): 02/15/2017

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: 09/16/2017
• Device Model Number: CY010
• Device Catalogue Number: 101419901
• Device Lot Number: 1231356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2015
• Initial Report FDA Received Date: 02/15/2017
• Patient Sequence Number: 1