MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES A3213, CLAMP (SIZE 5-60); DXC

Model Number	1
Medical Device Problem Code	Failure To Adhere Or Bond (1031)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/10/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was returned and was visually inspected for non-conformances such as jaw alignment and boxlock damages.Based on the customer's feedback, only the jaw alignment testing was performed as they noted "when you close the clamp the jaws are not aligned, they scissor." the returned clamp met visual and jaw alignment specifications, and the customer's experience of "scissoring" could not be confirmed.No visual non-conformances were found, but 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
Aortic valve substitution - "the clamp doesn't close the jaws properly.We had already sent a product replacement.The customer is not waiting for any further action, unless the pickup of the product by the courier.When we'll have the product, we'll send back to the office for inspection for our internal records." type of intervention - "n/a." patient status - "good.".

• Brand Name: A3213, CLAMP (SIZE 5-60)
• Common Device Name: DXC
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6368584
• Report Number: 2027111-2017-01435
• Device Sequence Number: 1081534
• Product Code: DXC
• UDI-Device Identifier: 00607915112691
• UDI-Public: (01)00607915112691(11)290330(30)01(10)1220223
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: 1
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• 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 Model Number: 1
• Device Catalogue Number: 1
• Device Lot Number: 1220223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2015
• Initial Report FDA Received Date: 03/01/2017
• Patient Sequence Number: 1