MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC.; GENERAL LAPAROSCOPY PACK

Device Problem Insufficient Information (3190)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 01/13/2016

Event Type  Injury  

Manufacturer Narrative

During a procedure, two small burns under the umbilicus resulted when the cautery device would not turn off.The burns were treated with an antibiotic ointment and a silver cream.No additional intervention was indicated.No serious injury resulted.The sample was not returned for evaluation.It was reported that the push button stuck, but then shut off after pushing the button a few times.Without a sample, we are unable to confirm that the push buttons were not functioning correctly.A root cause has not been determined.Due to the reported incident, this medwatch is being filed.

Event Description

The patient suffered two small burns from the cautery device.

• Type of Device: GENERAL LAPAROSCOPY PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• Manufacturer Contact: diane christensen ; one medline place; mundelein, IL 60060 ; 8476434747
• MDR Report Key: 5430601
• MDR Text Key: 38055703
• Report Number: 1423395-2016-00010
• 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: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 01/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2015
• 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