MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE INDUSTRIES, INC.; NEURO CDS

Model Number	CDS985246K
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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".
Additional Manufacturer Narrative
Report was filed under the incorrect manufacturing id 1417592-2023-00069.An additional mdr will be filed under the correct manufacturing id 1423395-2023-00007.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: 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: 16417869
• Report Number: 1417592-2023-00069
• Device Sequence Number: 17020153
• Product Code: OJG
• UDI-Device Identifier: 10195327324704
• UDI-Public: 10195327324704
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: CDS985246K
• Device Catalogue Number: CDS985246K
• Device Lot Number: 22JMC941
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2023
• Supplement Date Received by Manufacturer: 01/26/2023
• Initial Report FDA Received Date: 02/22/2023
• Supplement Report FDA Received Date: 02/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown