MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; SPINAL PACK SURGERY-LF

Catalog Number DYNJ0868974X

Device Problem Fire (1245)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/19/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported that soon after starting a vascular approach/exposure for an anterior lumbar inter-body fusion (alif) a flame appeared on the distal end of the bovie tip connected to the bovie pencil.At the time of the incident the surgeon reported no injury to the patient.No impact to the patient or procedure was noted.No additional information is available.The sample of the bovie was received for evaluation, the tip and the rest of the pack was not received for manufacturer investigation.Upon inspection of the received device there was no physical damage seen on the device.There was no indication of sparking or flame on the received device but this could be due to the fact that the tip was not received back for investigation.No root cause could be determined.Due to the report of a fire, this medwatch is being filed.If additional information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that during a procedure, the cautery device caught on fire.

• Type of Device: SPINAL PACK SURGERY-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, il ; 6434960
• MDR Report Key: 10240643
• MDR Text Key: 198490629
• Report Number: 1423395-2020-00015
• Device Sequence Number: 1
• Product Code: OJH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ0868974X
• Device Lot Number: 20ABQ419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2020
• Date Manufacturer Received: 06/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 49 YR
• Patient Weight: 124