MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-02-28 for LEICA M220 F12 manufactured by Leica Microsystems (schweiz) Ag.
[141220667]
This is a combined initial/final report. (b)(4) has performed a root cause investigation which revealed that the failure mode is related to a loose screw in the swing arm of the leica m220 f12 which is holding the optics carrier in place. The device showed, that there was insufficient amount of high strength thread adhesive applied to the screw. The identified root cause is a weakness in the gluing process intended to secure the screw connecting the optics carrier to the free end of the swing arm. On (b)(6) 2017 the gluing process at the supplier of the swing arm was changed by reducing the amount of high strength thread adhesive (weicon an302-70) applied to the screw. With the reduced amount of high strength thread adhesive, a reliable fixation of the screw can no longer be guaranteed. Consequently, it is possible that the screw connecting the optics carrier to the free end of the swing arm will loosen which subsequently can result in the optics carrier to fall. An enhancement of the design was introduced and a field safety corrective action was initiated to address the issue. It was found that the device mentioned in this submission is within the identified batch of potentially defective devices. This device was part of a correction report submitted to fda on 02 january 2019. We have not received a recall number from fda yet. For details refer to health hazard evaluation (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[141220668]
(b)(4) received a complaint from (b)(6) stating that on (b)(6) 2019 the optics carrier of a leica m220 f12 fell down after surgery. There was no patient/user injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003974370-2019-00002 |
| MDR Report Key | 8377112 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-02-28 |
| Date of Report | 2019-02-28 |
| Date of Event | 2019-02-06 |
| Date Mfgr Received | 2018-02-06 |
| Device Manufacturer Date | 2018-06-01 |
| Date Added to Maude | 2019-02-28 |
| 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 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | REFER TO H10 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEICA M220 F12 |
| Generic Name | SURGIAL MICROSCOPE |
| Product Code | FSO |
| Date Received | 2019-02-28 |
| 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 | 2019-02-28 |