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

Catalog Number DYNJ27379M

Device Problem Device Fell (4014)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/15/2018

Event Type  malfunction  

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 Description

It was reported that during a microdiscectomy procedure, raytec fibers from the covidien gauze were found to have fallen into the surgical site.

• Type of Device: COVIDIEN GAUZE IN LUMBAR PACK-LF
• Manufacturer (Section D): MEDTRONIC (COVIDIEN); 710 medtronic parkway; minneapolis MN 55432 5604
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753 ; 2249311458
• MDR Report Key: 8010849
• MDR Text Key: 125281318
• Report Number: 1423395-2018-00056
• Device Sequence Number: 1
• Product Code: OJH
• UDI-Device Identifier: 10889942846436
• UDI-Public: 10889942846436
• 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: Nurse
• Type of Report: Initial
• Report Date: 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ27379M
• Device Lot Number: 18FBV501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2018
• 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: 28 YR
• Patient Weight: 93