MAUDE Adverse Event Report: LEICA MICROSYSTEMS (SCHWEIZ) AG PROVIDO; SURGIAL MICROSCOPE

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

Patient Problems Injury (2348); Burn, Thermal (2530); No Known Impact Or Consequence To Patient (2692)

Event Date 07/05/2019

Event Type  malfunction  

Manufacturer Narrative

An investigation of the incident is currently underway and a follow-up will be submitted should additional information become available following investigation.

Event Description

Leica microsystems (b)(4) received a complaint from (b)(6) stating that a patient burn has occurred during a cochlear implantation surgery with a provido.The burn was described as a 1st degree burn.It is not yet known what might have caused the burn.

Manufacturer Narrative

This is a final report.The root cause why both lamps of the m525 f50 turned off during surgery could not be determined.An investigation of the reported behaviour was not possible as the customer refused access to the allegedly defective parts.The fse checked the service records if there were any indications out of previous service activities which could explain the complaint.Nothing was found which could explain the complaint.A review of the complaint statistic did not reveal any adverse trend for the m525.During a meeting with the customer the fse did a final attempt to get access to the allegedly defective parts for investigation.The customer stated, that there have been surgeries several times a day and the issue has not reoccurred since the event in (b)(6) 2019.Based on the unavailability of the defective parts together with the information of the customer, that the device is in daily use without issues, the complaint investigation will be closed as "ntf" (no trouble found) without further in-depth investigation.

Manufacturer Narrative

This is a final report.An initial assessment revealed: - the device history record showed that the device was tested and found to function according to specification.- the service records of the affected device were reviewed and it was found, that the xy-unit of the affected provido got damaged during transportation from the factory in singapore to south africa and required repair.Due to the transportation damage it could not be ruled out that a defect or device malfunction has caused or contributed to the 1st degree burn.During investigation of the actual complaint it was found, that the device functions according to specification.As such it is concluded, that the previous service case, damage during transport, did not cause the actual complaint.An on-site investigation on the actual device revealed: - the actual measured light intensity is within specified range - brightcare light intensity reduction is inactive as the actual values are below the threshold - the light intensity reduction functions according to specification additionally a visual inspection of the entire light chain in respect to possible transportation damages was performed: - collector lens as specified (not broken) and in center place to fiber cable input - filter wheel at correct position in center to beam - shutter wheel in correct position (full hole in center of beam at 100%) - fiber cable fully inserted as specified - no fiber cable damage anywhere the device was found to function according to specification.The device was monitored for 6 months with no further issues reported.The results of the investigation demonstrate that the provido functions according to specification.Based on the investigation it is unlikely that the injury, a 1st degree burn, was directly caused by the provido.During a follow up of the fse, the surgeon stated that the patient burn might have been caused by a hot metal clamp.The metal clamp got heated up as it was inside the illuminated field.We suspect that this is the root cause that has led to the 1st degree burn.Corrected data: follow-up # 01 was erroneously submitted with the data of 3003974370-2019-00004.With follow-up # 02 we submit the correct data of 3003974370-2019-00006.

• Brand Name: PROVIDO
• Type of Device: SURGIAL MICROSCOPE
• Manufacturer (Section D): LEICA MICROSYSTEMS (SCHWEIZ) AG; max-schmidheiny-strasse 201; heerbrugg, 9435 ; SZ 9435
• MDR Report Key: 8835414
• MDR Text Key: 216376558
• Report Number: 3003974370-2019-00006
• Device Sequence Number: 1
• Product Code: EPT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1