MAUDE Adverse Event Report: CARDINAL HEALTH 7317 SPG VISTEC 4X4 STR 10'S; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number	7317
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that the raytecs were shredding when being removed from the patient.Per customer, the original intended procedure was robotic paraoesophageal hernia repair.There was no patient harm.
Additional Manufacturer Narrative
The lot number was provided, and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.The product was released on 12-aug-2021.No physical sample was provided for the analysis; however, pictures were provided for the evaluation.Upon review, minor fraying could be seen.Therefore, the reported issue is confirmed.The root cause is the set screws for the heat roller on the machine (vistec autobander) were loose leading to element not being heated to the required temperature to bond with the gauze.As a preventive measure, manufacturing associates involved with the process to produce this product have been made aware of the issue and to be alert to this kind of issue.Samples were sent to the production for further awareness.The set screws for the heat roller on the machine are being monitored for looseness.
Additional Manufacturer Narrative
Section b5 has been updated to include additional information.
Event or Problem Description
The customer reported that the raytecs were shredding when being removed from the patient.Per customer, the original intended procedure was robotic paraoesophageal hernia repair.There was no patient harm.Additional information was received from the customer and stated that the shredding fibers were noticed during the robotic paraoesophageal hernia repair procedure and it was retrieved with a robotic grasper.The customer further stated that no medical intervention was required, and no additional procedures were performed.

• Brand Name: 7317 SPG VISTEC 4X4 STR 10'S
• Common Device Name: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 1430 marvin griffin road, po b; augusta GA 30906
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 14547106
• Report Number: 1018120-2022-00466
• Device Sequence Number: 6633209
• Product Code: GDY
• UDI-Device Identifier: 10884527016990
• UDI-Public: 10884527016990
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/09/2022

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 Model Number: 7317
• Device Catalogue Number: 7317
• Device Lot Number: 21H032762
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/20/2022
• Supplement Date Received by Manufacturer: 05/20/2022; 05/20/2022
• Initial Report FDA Received Date: 05/31/2022
• Supplement Report FDA Received Date: 06/03/2022; 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Female