MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-07-06 for LEICA M820 F40 manufactured by Leica Microsystems (schweiz) Ag.
[113301359]
This is a combined initial and final report. Patient information has been requested. However, the user facility declined to provide this information to the manufacturer due to data privacy laws in eu. A sales representative of leica microsystems (b)(4) checked the configuration of the device on site and took pictures. There was no device failure visible. A test made at leica microsystems (b)(4) by subject matter experts on a sample device showed that when fitting the stereo attachment to the beam splitter there is a clicking sound which indicates that it engaged. Once the knurled ring is tightened the stereo attachment cannot fall. We conclude that the incident is caused by a user error. The user failed to follow the instructions given in the user manual (leica m844 - leica m820 / ref. 10 713 294 / version 00) on page 18. The sales representative re-trained the staff on how to attach the stereo attachment to the beam splitter. Furthermore he suggested the customer to purchase a rotatable beam splitter in order to avoid the assembly and disassembly when switching from one side to the other.
Patient Sequence No: 1, Text Type: N, H10
[113301360]
Leica microsystems (b)(4) received a complaint from france stating that prior to surgery the stereo attachment and binocular tube fell onto patient's face causing a broken nose and a cut below the eye. The surgery was not performed due to swelling and shock.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003974370-2018-00006 |
| MDR Report Key | 7665996 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-07-06 |
| Date of Report | 2018-07-06 |
| Date of Event | 2018-06-18 |
| Date Mfgr Received | 2018-06-18 |
| Device Manufacturer Date | 2005-12-02 |
| Date Added to Maude | 2018-07-06 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 M820 F40 |
| Generic Name | SURGICAL MICROSCOPE |
| Product Code | FSO |
| Date Received | 2018-07-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 1. Required No Informationntervention | 2018-07-06 |