MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-09-21 for LEICA M525 F40 manufactured by Leica Microsystems (schweiz) Ag.
[120968159]
An initial investigation based on pictures provided by the customer indicates, that the user failed to follow the instructions given in the user manual. The m525 f40 was not returned into transport position before movement. It was moved while the unit was stretched out. Furthermore, the m525 f40 was pulled although it states in the user manual it shall be pushed. Moreover, one person pulled the device on the hand grips attached to the optics carrier. Also, we could identify a non-authorized modification of the device. The monitor and the monitor arm we could see on the pictures were not provided by leica microsystems. It cannot be ruled out that this modification contributed to the tipping over of the m525 f40. Further investigation of the incident is currently underway and a follow-up will be submitted should additional information become available following investigation.
Patient Sequence No: 1, Text Type: N, H10
[120968160]
Leica microsystems (b)(4) received a complaint from china stating that on (b)(6) 2018 the m525 f40 tipped over during preparation for a neuro surgery. There was no patient / user injury reported. The surgery was performed as scheduled with the same device. A similar incident happened on (b)(6) 2018 at the same site. Both incidents were reported on (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003974370-2018-00011 |
| MDR Report Key | 7896932 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-09-21 |
| Date of Report | 2018-10-02 |
| Date of Event | 2018-08-26 |
| Date Mfgr Received | 2018-08-26 |
| Device Manufacturer Date | 2013-05-22 |
| Date Added to Maude | 2018-09-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ROLAND JEHLE |
| Manufacturer Street | MAX-SCHMIDHEINY-STRASSE 201 |
| Manufacturer City | HEERBRUGG, SANKT GALLEN 9435 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 9435 |
| Manufacturer G1 | LEICA INSTRUMENTS (SINGAPORE) PTE LTD |
| Manufacturer Street | 12 TEBAN GARDENS CRESCENT |
| Manufacturer City | SINGAPORE, SINGAPORE 608924 |
| Manufacturer Country | SN |
| Manufacturer Postal Code | 608924 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEICA M525 F40 |
| Generic Name | SURGIAL MICROSCOPE |
| Product Code | EPT |
| Date Received | 2018-09-21 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEICA MICROSYSTEMS (SCHWEIZ) AG |
| Manufacturer Address | MAX-SCHMIDHEINY-STRASSE 201 HEERBRUGG, SANKT GALLEN 9435 SZ 9435 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-21 |