MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; CAUTERY DEVICE IN MAJOR SINGLE BASIN

Catalog Number DYNJHTSS13A

Device Problems Material Fragmentation (1261); Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/03/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that during a tlif spine procedure, the cautery device tip was identified to be flaking.When this flaking was identified the cautery device was removed from the field and the tip was replaced.The procedure continued without further reported incident.Reportedly, the flakes were "so small you can't see it." no irrigation or removal of the flakes occurred.There was no reported impact or adverse effect to the patient.A sample of only the cautery device tip was returned to the manufacturer for evaluation.Visual inspection of the sample confirmed the reported flaking of the cautery device tip.No information was submitted in regard to the settings and use of the cautery of device or the settings and type of generator used at the time of the incident.A root cause for the reported incident could not be determined.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 the cautery device tip was flaking and flakes fell into the surgical site.

• Type of Device: CAUTERY DEVICE IN MAJOR SINGLE BASIN
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753 ; 2249311458
• MDR Report Key: 8721921
• MDR Text Key: 149130655
• Report Number: 1423395-2019-00021
• Device Sequence Number: 1
• Product Code: FDE
• 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: 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNJHTSS13A
• Device Lot Number: 19BBH254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Weight: 95