MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-07-20 for LEICA MICROSYSTEMS M720 OH5 manufactured by Leica Microsystems (schweiz) Ag.
[49981972]
An investigation of the incident is currently underway and a follow up will be submitted should additional information become available following the investigation. Date of event: is not known as the customer was not aware of an overheating issue. He did not identify the smoke as such but thought that it was an illumination problem. It was the leica field service engineer who detected the problem on (b)(6) 2016.
Patient Sequence No: 1, Text Type: N, H10
[49981973]
Leica microsystems (b)(4) received a complaint on (b)(6) 2016 from (b)(6) stating that there is an overheating issue between the m720 optics carrier and the sterile drape which causes smoke and a melting of the drape. The surgery was completed and there was no patient/user injury.
Patient Sequence No: 1, Text Type: D, B5
[54425705]
This is a follow-up report. Visual inspection was performed by the responsible leica field service engineer on site. The defective parts of the affected device have been returned and are available for evaluation. The investigation has been performed by the specification developer and will be continued on further representative samples. The final report will be submitted once the investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
[55123667]
This is a final report. The affected parts (protective glass holder and protective drape glass) have been returned by the end user. An investigation on the affected parts and a representative sample has been performed by the specification developer. In addition, the design of the part and the accompanying documents (e. G. User manual) of the device have been reviewed. It was found that the used part is not compatible with the used optics carrier (m720). This part is compatible for the m720 sai optics carrier only due to a different diameter. The diameter of the used part interferes with the light path of the illumination due to a different size of diameter. The heat of the illumination led to this damaged protective glass holder that consists of plastic material and consequently melted which resulted in smoke. The user manual for m720 and m720 sai optics carriers does not clearly differentiate between the different types of drapes and the protective glasses. It can be interpreted that both can be used for both optics carrier because mechanically both are fully compatible. Consequently a capa has been initiated to correct this issue and clearly define which protective glass holder is intended to be used for the m720 optics carrier in the user manual. Based on a review of the complaint statistic the probability of occurrence is evaluated as remote because there is no similar case known. Consequently this event can be considered as an isolated event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003974370-2016-00008 |
| MDR Report Key | 5808653 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-07-20 |
| Date of Report | 2016-07-05 |
| Date of Event | 2016-07-05 |
| Date Mfgr Received | 2016-07-06 |
| Date Added to Maude | 2016-07-20 |
| 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 | 12 TEBAN GARDENS CRESCENT |
| Manufacturer City | SINGAPORE, 608924 |
| Manufacturer Country | SN |
| Manufacturer Postal | 608924 |
| Manufacturer Phone | 1717263216 |
| Manufacturer G1 | LEICA MICROSYSTEMS |
| Manufacturer Street | MAX SCHMIDHEINY STRASSE 201 |
| Manufacturer City | HEERBRUGG, ST. GALLEN 9435 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 9435 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEICA MICROSYSTEMS |
| Generic Name | LEICA M720 OH5, |
| Product Code | EPT |
| Date Received | 2016-07-20 |
| Model Number | M720 OH5 |
| Operator | PHYSICIAN |
| 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, ST. GALLEN 9435 SZ 9435 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-07-20 |