MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; NEURO CDS

Catalog Number CDS985246K

Device Problem Connection Problem (2900)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/25/2024

Event Type  Injury  

Manufacturer Narrative

It was reported by the customer that on (b)(6) 2024, the "plastic guard" of the bovie tip "fell off into the patient".It was reported that the piece was retrieved and the patient was not harmed.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 is a reportable event.If additional information becomes available this report will be reopened and reevaluated.

Event Description

The "plastic guard" of the bovie tip "fell off into the patient".

• Type of Device: NEURO CDS
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18760259
• MDR Text Key: 336053145
• Report Number: 1423395-2024-00049
• Device Sequence Number: 1
• Product Code: OJG
• 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: 02/22/2024

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 Catalogue Number: CDS985246K
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/26/2024
• Initial Date FDA Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other