MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline Industries, Inc.; NEURO CDS

Model Number CDS985246K

Device Problem Break (1069)

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

Event Date 01/26/2023

Event Type  Injury  

Manufacturer Narrative

According to the customer, on (b)(6) 2023 during a "multi-level lumbar lami case" when using a neuro custom pack the insulation bovie tip fell off and "was recovered in the surgical wound intact".The customer reported that after the incident another sterile insulated bovie tip was opened and used.The customer reported there was no medical intervention or serious injury related to the reported incident.No additional information is available at this time.Sample requested to be returned.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

According to the customer, on (b)(6) 2023 during a "multi-level lumbar lami case" when using a neuro custom pack the insulation bovie tip fell off and "was recovered in the surgical wound intact".

• Brand Name: Medline Industries, Inc.
• Type of Device: NEURO CDS
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16419885
• MDR Text Key: 310002767
• Report Number: 1423395-2023-00007
• Device Sequence Number: 1
• Product Code: OJG
• UDI-Device Identifier: 10195327324704
• UDI-Public: 10195327324704
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/22/2023

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 Model Number: CDS985246K
• Device Catalogue Number: CDS985246K
• Device Lot Number: 22JMC941
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/26/2023
• Initial Date FDA Received: 02/22/2023
• 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): Other