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

Model Number M525 F50

Device Problems Electrical /Electronic Property Problem (1198); Defective Component (2292); Device Issue (2379); Defective Device (2588); Electrical Shorting (2926)

Patient Problems No Consequences Or Impact To Patient (2199); Patient Problem/Medical Problem (2688); No Known Impact Or Consequence To Patient (2692)

Event Date 09/29/2015

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 the investigation.

Event Description

Leica microsystems ((b)(4)) ag received a complaint from leica (b)(4) on (b)(6), 2015 stating that the m525 f50 got blocked during surgery.There was no light and no movement.The failure was caused by a defect on the remote control of the video camera.The incident happened during a maxillofacial (jaw cancer remove with arm free flap) surgery.The field service engineer went at site the same day and solved the problem partially in order to enable the surgeon to complete the case.There was no patient / user injury.

Manufacturer Narrative

This is a follow-up report.Visual inspection was performed by the responsible leica field service engineer on site.An investigation was conducted on the actual affected remote control by the manufacturer.Visual inspection and functional/electrical evaluation was performed.The reported malfunction was caused by an connector pin which touched the electro-conductive surface of the remote control enclosure.This resulted in a short circuit on the can bus with a subsequent loss of function of the surgical microscope.The root cause investigations are ongoing.The final report will be submitted once the investigation is completed.File attachments no files.

Event Description

Leica microsystems (b)(4) received a complaint from leica (b)(4) on (b)(4) 2015 stating that the m525 f50 got blocked during surgery.There was no light and no movement.The failure was caused by a defect on the remote control of the video camera.The incident happened during a maxillofacial (jaw cancer remove with arm free flap) surgery.The field service engineer went at site the same day and solved the problem partially in order to enable the surgeon to complete the case.There was no patient / user injury.

Manufacturer Narrative

This is a final report.During the course of investigation it was found that the reported malfunction was not reproducible.Further investigation showed that the original complaint information was incorrect.According to the responsible leica field service engineer on site the illumination was still available during surgery but could not be adjusted anymore.This observed malfunction is consistent with the results of the functional evaluation which was performed by the specification developer.Visual inspection and functional / electrical evaluations of the electrical component and samples were performed.In addition, all measures, tolerances and the design of video focus remote control switch were checked and reviewed.As a result of the investigation, it was identified that the malfunction was caused by a short circuit on the can bus which lead to the malfunction of the surgical microscope controls (e.G.Adjustment of illumination, movement of focus or magnification).In particular, a defect of the video focus remote control has been identified.The connector pins of the printed circuit board assembly (pcba) in the video focus remote control were touching the housing and as a result, caused a short circuit on the can bus.According to the investigation the used connector pin type of the pcba was different from the specification on the drawing.In addition, based on the review of the complaint statistics, the installed base and the investigation results, the probability of re-occurrence has been evaluated as remote.The surgical microscope was repaired and put back into service.

Event Description

Leica microsystems ((b)(4)) ag received a complaint from leica (b)(4) on (b)(6) 2015 stating that the m525 f50 got blocked during surgery.The illumination and movement of the microscope could not be adjusted anymore.The failure was caused by a defect on the remote control of the video camera.The incident happened during a maxillofacial (jaw cancer remove with arm free flap) surgery.The field service engineer went at site the same day and solved the problem partially in order to enable the surgeon to complete the case.There was no patient / user injury.

• Brand Name: LEICA M525 F50
• Type of Device: LEICA M525 F50
• Manufacturer (Section D): LEICA MICROSYSTEMS (SCHWEIZ) AG; max schmidheiny strasse 201; heerbrugg, st. gallen 9435 ; SZ 9435
• Manufacturer (Section G): LEICA MICROSYSTEMS (SCHWEIZ) AG; max schmidheiny strasse 201; heerbrugg, st. gallen 9435 ; SZ 9435
• Manufacturer Contact: roland jehle ; max schmidheiny strasse 201; heerbrugg, st. gallen 9435 ; SZ 9435 ; 1717263216
• MDR Report Key: 5179536
• MDR Text Key: 30047844
• Report Number: 3003974370-2015-00008
• Device Sequence Number: 1
• Product Code: EPT
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Physician
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup
• Report Date: 09/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: M525 F50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other