MAUDE Adverse Event Report: LEICA MICROSYSTEMS (SCHWEIZ) AG LEICA M525 F50; SURGICAL PROCEDURE

Model Number M525 F50

Device Problems Failure To Service (1563); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/15/2017

Event Type  malfunction  

Manufacturer Narrative

This is a combined initial and final report.According to the field service engineer's report, the user started the surgical procedure with the auxiliary (back-up) lamp with the knowledge that the main lamp was defective.During surgery, the used auxiliary lamp malfunctioned and as a result, the surgical microscope did not have any light at all.The surgical procedure was completed by another surgical microscope.As a result of the malfunction of both main and auxiliary lamps, a field service engineer (fse) was requested on site to repair the affected components.During repair, fse's analysis showed that the malfunction of the main lamp was caused by a defective ignitor and the malfunction of the auxiliary lamp was caused by a defective xenon power supply board.Further investigation was conducted by the manufacturer.The instructions for use was reviewed and it states that during preparation and prior to surgery, the main and auxiliary lamps shall undergo a function check to ensure that both lamps (main and auxiliary) are functioning.In addition, the timer for the xenon lamps shall be checked as well.However, the user continued to use the surgical microscope with a defective main lamp.In addition, the user failed to have the defective main lamp replaced and repaired during preparation and prior to surgery.Therefore, the manufacturer concludes that the incident was caused by use error, failure to service and failure to follow the manufacturer's instructions.

Event Description

On (b)(6) 2017, leica microsystems received a complaint stating that during a surgical procedure, both the xenon illumination of leica m525 f50 malfunctioned.

• Brand Name: LEICA M525 F50
• Type of Device: SURGICAL PROCEDURE
• Manufacturer (Section D): LEICA MICROSYSTEMS (SCHWEIZ) AG; max schmidheiny strasse 201; heerbrugg, st. 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, st. gallen 9435 ; SZ 9435 ; 717263216
• MDR Report Key: 6405363
• MDR Text Key: 69957100
• Report Number: 3003974370-2017-00003
• Device Sequence Number: 1
• Product Code: EPT
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 02/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M525 F50
• Device Catalogue Number: 10448422
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other