MAUDE Adverse Event Report: MEDTRONIC (COVIDIEN); COVIDIEN GAUZE IN LUMBAR PACK-LF

Catalog Number	DYNJ27379M
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that during a microdiscectomy procedure, raytec fibers from the covidien gauze were found to have fallen into the surgical site.The method used to retrieve the raytec fibers from the surgical site was not identified by the reporting facility.No impact to the patient, the patient's stability, or the patient's plan of care was reported.No impact to the procedure was reported.No serious injury or follow-up care was reported.No sample was available to be returned for evaluation.No additional information was provided by the reporting facility.A third-party notification was sent to the manufacturer of the raytec gauze.Due to the reported incident, 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 during a microdiscectomy procedure, raytec fibers from the covidien gauze were found to have fallen into the surgical site.

• Common Device Name: COVIDIEN GAUZE IN LUMBAR PACK-LF
• Manufacturer (Section D): MEDTRONIC (COVIDIEN); 710 medtronic parkway; minneapolis MN 55432 5604
• MDR Report Key: 8010849
• Report Number: 1423395-2018-00056
• Device Sequence Number: 13798620
• Product Code: OJH
• UDI-Device Identifier: 10889942846436
• UDI-Public: 10889942846436
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/26/2018

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ27379M
• Device Lot Number: 18FBV501
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2018
• Initial Report FDA Received Date: 10/26/2018
• 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: 28 YR
• Patient Weight: 93