MAUDE Adverse Event Report: LEICA MICROSYSTEMS (SCHWEIZ) AG LEICA M720 OH5; SURGICAL MICROSCOPE

Device Problems Degraded (1153); Naturally Worn (2988); Unintended Movement (3026); Noise, Audible (3273)

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

Event Date 07/19/2019

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.(b)(6).

Event Description

Leica microsystems (schweiz) ag received a complaint from (b)(6) stating that during a repair work on (b)(6) 2019 of a m720 oh5, the field service engineer (fse) found that the base brake was defective.The brake did not always engage properly.This can end up in the brake releasing inadvertently by itself during surgery, which can cause loud noise and vibration of the device that can influence the surgeon's performance.Since the malfunction was found by our fse, there was no complaint reported by the customer.However, our fse informed the customer accordingly.There was no patient injury reported.

Manufacturer Narrative

During a repair work on july 19, 2019 of a m720 oh5, the field service engineer (fse) found that the base brake was defective.The base brake did not always engage properly.As root cause a worn out part (base brake latch) was identified during an on-site inspection by the fse.A review of the complaint databank revealed a complaint with identical failure mode which occured during surgery on a m720 oh5 in france, in (b)(6) 2014 (complaint number (b)(4)).A review of (b)(4) and related documentation was performed.Results showed that there were no (0) similar or identical complaints reported since the year 2014 when complaint (b)(4) occurred (with the exception of this complaint (b)(4)).A review of the service manual showed, that following (b)(4) it was enhanced in november 2014 (v4.2) to include test and inspection of the foot brake.For this complaint (b)(4) the issue was detected during repair and maintenance of the device.The brake of the affected m720 oh5 s/n oh5-31011 was repaired in august 2019.A follow-up on-site visit for maintenance and inspection on the affected device was conducted in december 2019.In addition, a follow up interview was performed with the responsible fse on-site on 12.12.2019 because the service report (b)(4) did not state any information regarding the brake.The fse clarified, that there were no further issues with the foot brake since the repair in august 2019.The repair of the base brake was effective.The reported issue is an isolated event with no further actions required.

• Brand Name: LEICA M720 OH5
• Type of Device: SURGICAL MICROSCOPE
• Manufacturer (Section D): LEICA MICROSYSTEMS (SCHWEIZ) AG; max-schmidheiny-strasse 201; heerbrugg, sankt gallen, 9435 ; SZ 9435
• MDR Report Key: 8878187
• MDR Text Key: 217437023
• Report Number: 3003974370-2019-00007
• 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
• Report Date: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1