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

Model Number RCL35

Device Problems Device Operates Differently Than Expected (2913); Physical Property Issue (3008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/02/2017

Event Type  Injury  

Event 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.

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
• Type of Device: MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• Manufacturer (Section G): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• Manufacturer Contact: amy clendening-wheeler ; one allentown parkway; allen, TX 75002
• MDR Report Key: 6621327
• MDR Text Key: 76953356
• Report Number: 1649914-2017-00046
• Device Sequence Number: 1
• Product Code: DWS
• UDI-Device Identifier: 10634624373508
• UDI-Public: 10634624373508
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Physician
• Device Expiration Date: 05/04/2019
• Device Model Number: RCL35
• Device Lot Number: 0513366Y04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2017
• Initial Date FDA Received: 06/08/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Weight: 64