MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; THORACOSCOPY PACK

Catalog Number DYNJ9425843L

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/26/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported that a patient was undergoing a right video-assisted thoracoscopic surgery (vats) wedge procedure and the surgeon found a broken bovie sleeve after the wedge resection was complete.Per the reporter, the surgeon was inspecting the surgical site before closing and the broken bovie tip was seen in the chest.The bovie tip was retrieved intact with a sponge stick.The retrieval took approximately 5 minutes and no additional anesthesia or medication was required.There was no report of any adverse patient consequence and no effect on the patient's stability as a result of the incident.There were no complications noted with the patient during or after the procedure.The actual device is not going to be returned to medline for evaluation.Due to the reported incident and 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 Description

It was reported that the cautery device broke off during a procedure and had to be manually removed.

• Type of Device: THORACOSCOPY PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 10549952
• MDR Text Key: 232209918
• Report Number: 1423395-2020-00026
• Device Sequence Number: 1
• Product Code: LRO
• 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: Other
• Type of Report: Initial
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ9425843L
• Device Lot Number: 20EKA540
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 72