MAUDE Adverse Event Report: MEDLINE INDUSTRUIES LP MEDLINE INDUSTRIES, INC.; ROBOTIC PACK

Model Number	DYNJ0744881I
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that in the middle of the robotic hysterectomy, pieces of string were discovered inside the patient's surgical site from the gauze sponge.The facility reported that the gauze was placed through a robotic port into the body and shredded into the body.A grasping instrument was used to remove the pieces of string.An x-ray was performed to ensure there was no retained foreign objects.The facility reported the patient did require intervention and was under general anesthesia longer due to the incident however there was no reported impact to the patient's stability and discharge was anticipated to be one day post-op.No sample was returned to the manufacturer for evaluation.No additional information is available.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that in the middle of the procedure pieces of string were discovered inside the patient's surgical site from the gauze sponge.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: ROBOTIC PACK
• Manufacturer (Section D): MEDLINE INDUSTRUIES LP; three lakes drive; northfield IL 60093
• MDR Report Key: 12706343
• Report Number: 1423395-2021-00051
• Device Sequence Number: 16510825
• Product Code: OHD
• UDI-Device Identifier: 10193489943245
• UDI-Public: 10193489943245
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/27/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: DYNJ0744881I
• Device Catalogue Number: DYNJ0744881I
• Device Lot Number: 21HBQ510
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 10/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Weight: 63