MAUDE Adverse Event Report: LEICA MICROSYSTEMS (SCHWEIZ) AG LEICA M320; MICROSCOPE, SURGICAL

Model Number M530 OH6

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn, Thermal (2530)

Event Date 06/26/2019

Event Type  malfunction  

Event Description

An event was reported to patient safety, after undergoing a rhizotomy, it was discovered that the patient had what appeared to be an approximately 2.5 cm size burn on her back, next to the incision.It was suspected that this resulted from a microscope that was used during the procedure.Immediately after discovering this, plastic surgery was called for a consultation and a disclosure was made to the parents.The patient is recovering well from this and is scheduled for discharge, later today.After discharge, the patient will be closely assessed for any signs of infection and to make sure the wound is healing.Biomedical engineering was contacted and the microscope sequestered to validate it is functioning appropriately.

Event Description

An event was reported to patient safety, after undergoing a rhizotomy, it was discovered that the patient had what appeared to be an approximately 2.5 cm size burn on her back, next to the incision.It was suspected that this resulted from a microscope that was used during the procedure.Immediately after discovering this, plastic surgery was called for a consultation and a disclosure was made to the parents.The patient is recovering well from this and is scheduled for discharge, later today.After discharge, the patient will be closely assessed for any signs of infection and to make sure the wound is healing.Biomedical engineering was contacted and the microscope sequestered to validate it is functioning appropriately.

• Brand Name: LEICA M320
• Type of Device: MICROSCOPE, SURGICAL
• Manufacturer (Section D): LEICA MICROSYSTEMS (SCHWEIZ) AG; 1700 leider lane; buffalo grove IL 60089
• MDR Report Key: 9213513
• MDR Text Key: 163020451
• Report Number: 9213513
• Device Sequence Number: 1
• Product Code: EPT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M530 OH6
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/01/2019
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/21/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 4380 DA