MAUDE Adverse Event Report: QUEST MEDICAL, INC. PERFECTCUT ROTATING AORTIC PUNCH

Model Number	RCB40
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Quest medical received the suspect medical device on 11/10/2022.After decontamination, the device was tested and was found to engage/disengage as intended.The complaint condition could not be replicated.Quest will continue to monitor complaint trends.
Event or Problem Description
It was reported to quest medical by the university of arkansas for medical sciences of an alleged issue with the aortic punch.Allegedly, the punch has several occurences where it got stuck during use and would not release.

• Brand Name: PERFECTCUT ROTATING AORTIC PUNCH
• Common Device Name: AORTIC PUNCH
• Manufacturer (Section D): QUEST MEDICAL, INC.; 1 allentown parkway; allen TX 75002
• Manufacturer (Section G): QUEST MEDICAL, INC.; 1 allentown parkway; allen TX 75002
• Manufacturer Contact: brian hedden ; 1 allentown parkway; allen, TX 75002 ; 9723326311
• MDR Report Key: 15911387
• Report Number: 1649914-2022-00035
• Device Sequence Number: 4384628
• Product Code: DWS
• UDI-Device Identifier: 10634624324005
• UDI-Public: 10634624324005
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/02/2022

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
• Device Model Number: RCB40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2022
• Initial Report FDA Received Date: 12/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown