MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; XRD GAUZE IN GYNE ROBOTIC PACK

Catalog Number	DYNJ66107
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the xrd gauze tore during a robotic hysterectomy procedure.Reportedly, the tear occurred as the surgeon was pulling the xrd gauze out of the abdomen through a trocar that was in use.The torn xrd gauze piece fell back into the abdomen and was able to be retrieved by the surgeon using a laparoscopic grasper and crile.The robotic hysterectomy procedure was completed without further reported incident.According to the reporting facility, the procedure was extended for approximately 5-10 minutes to retrieve the torn xrd gauze piece.No serious injury was identified and the patient did not require follow-up care.No sample was available to be returned to the manufacturer for evaluation.A root cause was unable to be determined.Due to the reported need for medical intervention to retrieve the torn xrd gauze piece, 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 the x-ray detectable (xrd) gauze tore during a procedure.

• Common Device Name: XRD GAUZE IN GYNE ROBOTIC PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 11003016
• Report Number: 1423395-2020-00046
• Device Sequence Number: 690674
• Product Code: OHD
• UDI-Device Identifier: 10193489320121
• UDI-Public: 10193489320121
• 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,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/14/2020

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
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ66107
• Device Lot Number: 20EBS023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 12/14/2020
• 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: 78 YR
• Patient Weight: 78