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

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

Patient Problems Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)

Event Date 07/31/2019

Event Type  Injury  

Manufacturer Narrative

This is a combined initial and final report.On october 24, 2019 leica microsystems (schweiz) ag received a user facility medwatch form fda 3500a report (0533010000-2019-8008) from our importer stating that there was a reported patient burn at (b)(6).(b)(6) reported a patient incident with a leica microsystems m320 surgical microscope (serial number (b)(4)) in june 2019.Upon internal investigation, leica microsystems determined that leica microsystems had no record of a reported incident involving a m320 surgical microscope (serial number (b)(4)) in (b)(6) 2019.Leica microsystems became aware of a patient incident at (b)(6) on (b)(6) 2019.This complaint was for a reported patient burn at (b)(6).The affected leica surgical microscope was an arveo (also referenced as m530 oh6) (serial number (b)(4)).This incident was investigated per leica microsystems procedures and was determined that the arveo surgical microscope device unlikely caused or contributed to patient injury and therefore, the complaint was not reportable to the us-fda in accordance to 21 cfr 803.50.Upon receipt of medwatch form (0533010000-2019-8008) on (b)(6) 2019, leica microsystems contacted (b)(6) (biomedical engineer - ucsf benioff) to inquire about the source of this complaint.Mr.Lautenschlager indicated that this particular incident was investigated in august by leica representatives.Leica sales representatives were contacted and were unaware of this incident, stated to have occurred in (b)(6) 2019.Upon further investigation, it was determined that the incident reported in medwatch (0533010000-2019-8008) was filed in error as this incident was the same previously reported to leica microsystems on (b)(6) 2019.Errors in medwatch form (0533010000-2019-8008) include: model and serial number of affected microscope.Date of incident.Leica has asked mr.Lautenschlager to verify these errors and the corrected information.This is shown in attachment.A memo is also attached to clarify the product / device name as referenced in the supporting documents for the complaint investigation.Exemption number: (b)(4).Leica microsystems (schweiz) ag (the manufacturer) is also submitting the report on behalf of leica microsystems, inc.(the importer).

Event Description

On october 24, 2019 leica microsystems (schweiz) ag received a user facility medwatch form fda 3500a report (0533010000-2019-8008) from our importer stating that there was a reported patient burn at the (b)(6).

• Brand Name: ARVEO
• Type of Device: SURGICAL MICROSCOPE
• Manufacturer (Section D): LEICA MICROSYSTEMS (SCHWEIZ) AG; max-schmidheiny-strasse 201; heerbrugg, sankt gallen, 9435 ; SZ 9435
• Manufacturer (Section G): LEICA INSTRUMENTS (SINGAPORE) PTE LTD; 12 teban gardens crescent; singapore, 60892 4; SN 608924
• Manufacturer Contact: roland jehle ; max-schmidheiny-strasse 201; heerbrugg, sankt gallen, 9435 ; SZ 9435
• MDR Report Key: 9365643
• MDR Text Key: 168454135
• Report Number: 3003974370-2019-00013
• Device Sequence Number: 1
• Product Code: EPT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/24/2019,11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/24/2019
• Device Age: 18 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/24/2019
• Date Manufacturer Received: 10/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 12 YR