MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2017-02-27 for LEICA M300 10446587 manufactured by Leica Microsystems (schweiz) Ag.
[68372020]
This is a final report. The root cause for the malfunction is maintenance deficiency. The malfunction resulted from an improper service activity by a third party field service engineer (fse), who did not follow the manufacturer's instructions. The service activity occurred half a year prior to the incident. After dismantling the optics carrier fixation to the swing arm of the surgical microscope stand, the third party fse improperly re-used the screws when attaching the optics carrier after service. According to the manufacturer's instructions, the old screws must be exchanged with new screws after service and the manufacturer instructed to never to use screws twice. Re-using the screws twice allowed all three screws to get loose over time, which subsequently caused the optics carrier to fall down unexpectedly.
Patient Sequence No: 1, Text Type: N, H10
[68372021]
Leica microsystems ((b)(4)) (b)(4) received a complaint on (b)(6) 2017 from (b)(6) stating that on (b)(6) 2017, the optics carrier of a leica m300 fell onto patient's head during an ear examination.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003974370-2017-00002 |
| MDR Report Key | 6360227 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2017-02-27 |
| Date of Report | 2017-02-03 |
| Date of Event | 2017-02-02 |
| Device Manufacturer Date | 2007-08-30 |
| Date Added to Maude | 2017-02-27 |
| 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, ST. GALLEN 9435 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 9435 |
| Manufacturer Phone | 717263216 |
| Manufacturer G1 | LEICA INSTRUMENTS (SINGAPORE) PTE LTD |
| Manufacturer Street | 12 TEBAN GARDENS CRESCENT |
| Manufacturer City | 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 M300 |
| Generic Name | SURGICAL MICROSCOPE |
| Product Code | EPT |
| Date Received | 2017-02-27 |
| Model Number | M300 |
| Catalog Number | 10446587 |
| 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, ST. GALLEN 9435 SZ 9435 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-02-27 |