MAUDE Adverse Event Report: QUEST MEDICAL, INC. CLEANCUT ROTATING AORTIC PUNCH; MANUAL SURGICAL INSTRUMENT

Model Number	RCL35
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/02/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was forwarded a medwatch report, reference (b)(4), which alleged an issue encountered with the aortic punch during use.The report stated that the physician was completing a cabg and noted the aortic punch "would not cut or activate cutting device." there were no patient complications reported as a result of the alleged issue.The aortic punch was not returned to the manufacturer for evaluation.Follow up attempts with the user facility have not yet been answered.
Additional Manufacturer Narrative
Review of the device history record did not show any manufacturing or quality anomalies during production of this lot.The device was not returned to the manufacturer for evaluation.This product is 100% functionally inspected during manufacturing process with each part being activated multiple times to check for rough activation or jamming.

• Brand Name: CLEANCUT ROTATING AORTIC PUNCH
• Common Device Name: MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• MDR Report Key: 6621327
• Report Number: 1649914-2017-00046
• Device Sequence Number: 10959585
• Product Code: DWS
• UDI-Device Identifier: 10634624373508
• UDI-Public: 10634624373508
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 05/04/2019
• Device Model Number: RCL35
• Device Lot Number: 0513366Y04
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/09/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/08/2017
• Supplement Report FDA Received Date: 06/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Weight: 64