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

Model Number DYNJ0744881I

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/14/2021

Event Type  Injury  

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 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.
• Type of Device: ROBOTIC PACK
• Manufacturer (Section D): MEDLINE INDUSTRUIES LP; three lakes drive; northfield IL 60093
• MDR Report Key: 12706343
• MDR Text Key: 283670771
• Report Number: 1423395-2021-00051
• Device Sequence Number: 1
• Product Code: OHD
• UDI-Device Identifier: 10193489943245
• UDI-Public: 10193489943245
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DYNJ0744881I
• Device Catalogue Number: DYNJ0744881I
• Device Lot Number: 21HBQ510
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 63