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

Model Number	A3213
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/09/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident device is anticipated to return.A follow-up report will be provided upon completion of 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.
Event or Problem Description
Valvola aortica- "during operation, it doesn't close properly the jaws.We haven't had the opportunity to see the clamp, so the description of the event has been reported by the head nurse.We need to go to the customer to verify more deeply what was the problem and if the issue was caused by a misfunction of the clamp or by an improper usage of the customer." patient status - "good.".
Additional Manufacturer Narrative
This investigation for both mdr# 2027111-2016-00196 & 2027111-2016-00197.The device was used on both procedures.Investigation summary: one event unit was returned for evaluation.Upon functional testing, engineering performed a jaw alignment test and verified that the returned clamp met visual and jaw alignment specifications.All clamps undergo 100% visual inspection during the assembly and packaging process.Applied medical has reviewed the details surrounding the incident and related products.At this time, applied medical is unable to confirm that a product malfunction occurred.Additional information was requested and provided.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 the supplemental report will be submitted to the fda.

• Brand Name: A3213, CLAMP (SIZE 5-60)
• Common Device Name: DXC
• Manufacturer (Section D): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 5490642
• Report Number: 2027111-2016-00196
• Device Sequence Number: 1162423
• Product Code: DXC
• UDI-Device Identifier: 00607915112691
• UDI-Public: (01)00607915112691(11)140529(30)01(10)1223826
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K950492
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2016

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: Other
• Device Model Number: A3213
• Device Catalogue Number: 100792801
• Device Lot Number: 1223826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/09/2016
• Supplement Report FDA Received Date: 06/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1