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

Catalog Number DYNJ66107

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/23/2020

Event Type  Injury  

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 Description

It was reported that the x-ray detectable (xrd) gauze tore during a procedure.

• Type of Device: XRD GAUZE IN GYNE 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: 11003016
• MDR Text Key: 221270768
• Report Number: 1423395-2020-00046
• Device Sequence Number: 1
• Product Code: OHD
• UDI-Device Identifier: 10193489320121
• UDI-Public: 10193489320121
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ66107
• Device Lot Number: 20EBS023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 12/14/2020
• 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: 78 YR
• Patient Weight: 78