MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; SURGICAL GLOVES

Catalog Number MDS108075LT

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Manufacturer Narrative

An account reported that a "bovie burned the surgeons hand through the gloves.They are assuming there was holes in the glove or else it wouldn't have burned".It was later reported that the surgeon was burned while he was "buzzing the hemostat"."buzzing the hemostat" refers to heating up a hemostat with the cautery device, if there is an imperfection in the hemostat, the electrical current can move through the glove and penetrate to the skin."buzzing the hemostat" is not a recommended practice.Multiple attempts have been made to obtain additional details in regards to the severity of injury, treatment of the injury, if the surgeon was double gloved, and if there were actual integrity issues with the glove.It was reported the cautery device and the hemostat are not medline products.It is unknown who manufactures the cautery device and hemostat or if they have been notified of this incident.A sample was not been returned, however, gloves do not act as insulators against electrical currents that can cause burns.User-error cannot be ruled out as a possible root cause.Due to the reported incident and in an abundance of caution this medwatch is being filed.Device not returned.

Event Description

It was reported a glove contributed to a burn while in using a cautery device.

• Type of Device: SURGICAL GLOVES
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: megan debus ; three lakes drive; northfield, IL 60093
• MDR Report Key: 6662799
• MDR Text Key: 78235923
• Report Number: 1417592-2017-00049
• Device Sequence Number: 1
• Product Code: KGO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: MDS108075LT
• Device Lot Number: 702909468970
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 05/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other