MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; GYN ROBOTIC

Catalog Number	DYNJ900552P
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility, the grounding pad caused a severe burn to the patient's leg.
Additional Manufacturer Narrative
According to the facility, the grounding pad caused a severe burn to the patient's leg.Per the facility, the patient needed treatment from the plastic's team and needed to be transferred to another hospital for proper burn treatment as this facility does not care for burns.There is no information on what treatment was needed.No additional information at this time.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Common Device Name: GYN ROBOTIC
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; 3 lakes dr; northfield IL 60093
• Manufacturer Contact: alyssa reasner ; 3 lakes dr; northfield, IL 60093
• MDR Report Key: 23534228
• Report Number: 1423395-2025-00185
• Device Sequence Number: 15999028
• Product Code: OHD
• UDI-Device Identifier: 10195327517649
• UDI-Public: 10195327517649
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 11/12/2025

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 Expiration Date: 03/31/2026
• Device Catalogue Number: DYNJ900552P
• Device Lot Number: 25FMF288
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2025
• 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: Hospitalization; Other
• Patient Sex: Unknown