MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-07-03 for LEICA M650 manufactured by Leica Microsystems (schweiz) Ag.
[79639386]
This is a combined initial and final report. An on-site investigation was conducted by a leica representative. Upon visual examination of the affected part (broken bulb), it was shown that the broken bulb was not a leica bulb but a third party bulb. According to the leica representative, the user facility has been informed every service visit that they should use the correct (leica) bulb, which is recommended by the manufacturer. The user facility is aware of this but prefer to use a third party (non-leica) bulb. In addition, upon discussion with the user facility contact person, it was suggested that a fluid may have been sprayed close to the surgical microscope during use and this is what has caused the non-leica bulb to explode (ie droplets or moisture coming into contact with the hot glass of the bulb). The user facility has again fitted a new third party (non-leica) bulb and have run the surgical microscope for three days without any issues. A follow-up visit was conducted by a leica representative, who dismantled the optics carrier and removed all the broken glass from the damaged bulb and made sure that it was fully functional. The health care professional insisted that they will only use the surgical microscope if the user facility purchased the correct leica bulb. Hence, the leica representative supplied them with the correct leica bulbs. Note: the manufacturing date is unknown as this device has been manufactured more than 20 years ago and has been phased out in 1994.
Patient Sequence No: 1, Text Type: N, H10
[79639387]
Leica microsystems ((b)(4)) received a complaint on (b)(6) 2017 from (b)(6) stating that on (b)(6) 2017, a patient (child) was under anesthetic for an ent procedure where the leica m650 surgical microscope was in use. The microscope bulb exploded leaving the socket of the bulb attached in position, small glass fragments landed on the patient drape leaving burn marks on it. No harm came to the patient or operator.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003974370-2017-00008 |
| MDR Report Key | 6683975 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-07-03 |
| Date of Report | 2017-06-09 |
| Date of Event | 2017-06-01 |
| Date Mfgr Received | 2017-06-09 |
| Date Added to Maude | 2017-07-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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, 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 M650 |
| Generic Name | SURGICAL MICROSCOPE |
| Product Code | EPT |
| Date Received | 2017-07-03 |
| Model Number | M650 |
| 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, 9435 SZ 9435 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-07-03 |