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

Catalog Number DYNJ47688C

Device Problems Material Split, Cut or Torn (4008); Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2019

Event Type  malfunction  

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 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.

• Type of Device: GAUZE IN DBD-ROBOTIC PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753 ; 2249311458
• MDR Report Key: 8317514
• MDR Text Key: 135743340
• Report Number: 1423395-2019-00001
• Device Sequence Number: 1
• Product Code: FDE
• UDI-Device Identifier: 10889942190089
• UDI-Public: 10889942190089
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ47688C
• Device Lot Number: 18LKC867
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR