MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; GAUZE IN DBD-ROBOTIC PACK

Catalog Number	DYNJ47688C
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that as the gauze component was being removed from the surgical site, during a robotic gastrojejunostomy procedure, it ripped and a piece fell back into the surgical site.The gauze was being removed through a trocar at the time of the incident.When it was identified that the ripped piece fell back into the surgical site, it was removed through the trocar.The patient was under general anesthesia at the time of this incident.The procedure did not last longer than expected and the patient did not require additional anesthesia.There was no reported impact or adverse effect to the patient, the patient's stability, or the patient's plan of care.The reporting facility indicated that no sample was available to be returned to the manufacturer for evaluation.A root cause for the reported incident could not be determined.Due to the need for medical intervention to remove the ripped gauze piece from the surgical site, 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 as the gauze component was being removed from the surgical site, during a robotic gastrojejunostomy procedure, it ripped and a piece fell back into the surgical site.

• Common Device Name: GAUZE IN DBD-ROBOTIC PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 8317514
• Report Number: 1423395-2019-00001
• Device Sequence Number: 14010354
• Product Code: FDE
• UDI-Device Identifier: 10889942190089
• UDI-Public: 10889942190089
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ47688C
• Device Lot Number: 18LKC867
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2019
• Initial Report FDA Received Date: 02/07/2019
• 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