MAUDE Adverse Event Report: AMERICAN CONTRACT SYSTEMS PAC, CUSTOM ACS UNIVERSAL SET-UP JRSU11G

Model Number	JRSU11G
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	05/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product involved in the report is not available for evaluation.American contract systems is the manufacturer of the universal setup pack jrsu11g.The complaint component medtronic cautery pencil, part number e2516nhsb is manufactured by covidien (fda registration 1717344).The bovie pen is supposed to be holstered once it is powered on, as it creates heat.The bovie pen was not holstered while not in use.We have determined the injury occurred due to user error at the hospital.Because of this determination, a scar was not issued to the supplier of the bovie pen.This product incident is documented in the acs complaint database as 23-075 and adverse event assessment is identified as record ch-dt-2023-a1-20.This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a product is defective or has caused serious injury.
Event or Problem Description
A bovie pencil from universal set-up pack activated on its own when the plug was inserted into the robot.The patient was already prepped and draped for the procedure, no one was utilizing the bovie pencil at that time.The staff heard a buzzing sound and immediately realized it was the bovie pencil.The nurse pulled the plug, and the scrub tech threw device off the sterile field.Unfortunately, the patient was already burned.

• Brand Name: PAC, CUSTOM ACS UNIVERSAL SET-UP JRSU11G
• Common Device Name: PAC, CUSTOM ACS UNIVERSAL SET-UP JRSU11G
• Manufacturer (Section D): AMERICAN CONTRACT SYSTEMS; jackson pointe commerce; 4050 jackson pointe court; zelienople PA 16063
• Manufacturer (Section G): AMERICAN CONTRACT SYSEMS; jackson's pointe commerce park; 4050 jackson pointe court; zelienople PA 16063
• Manufacturer Contact: nichole early ; 1 edison drive; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 17167954
• Report Number: 3011389083-2023-00001
• Device Sequence Number: 5578161
• Product Code: LRO
• UDI-Device Identifier: 00191072140548
• UDI-Public: 00191072140548
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/20/2023

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: Health Professional
• Device Model Number: JRSU11G
• Device Catalogue Number: JRSU11G
• Device Lot Number: 893231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown