MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; DBD-GENERAL ROBOTICS PACK

Catalog Number	DYNJ64458I
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	Intraoperative Cardiac Injury (4855)
Date of Event	10/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer, when they unfolded the pack there was "hair in it", requiring the staff to "redo the setup", and the patient was "under anesthesia longer".
Additional Manufacturer Narrative
According to the customer, when they unfolded the pack there was "hair in it", requiring the staff to "redo the setup", and the patient was "under anesthesia longer".The customer reported the patient had "cardiac complications" after the procedure.No additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.No additional information is available.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Common Device Name: DBD-GENERAL ROBOTICS PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 20747115
• Report Number: 1423395-2024-00500
• Device Sequence Number: 8613730
• Product Code: OHD
• UDI-Device Identifier: 40195327527779
• UDI-Public: 40195327527779
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/21/2024

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 Expiration Date: 04/30/2026
• Device Catalogue Number: DYNJ64458I
• Device Lot Number: 24HMA723
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown