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 2016-06-16 for LEICA MICROSYSTEMS M844 C40 manufactured by Leica Microsystems (schweiz) Ag.
[47497034]
An investigation of the incident is currently underway and a follow up will be submitted should additional information become available following the investigation.
Patient Sequence No: 1, Text Type: N, H10
[47497035]
Leica microsystems ((b)(4)) ag received a complaint on june 6, 2016 from (b)(6) stating that a doctor "has banged his head" on the controller box shelf on an m844 c40 surgical microscope. He needed medical intervention because the injury was a deep laceration which needed stitching and gluing. The incident happened between two surgeries on the morning of the (b)(6). The surgeon had treatment and came back to continue performing surgeries. He was able to complete the scheduled list for that day.
Patient Sequence No: 1, Text Type: D, B5
[49981887]
This is a final report. The affected part was not returned for evaluation but the responsible leica field service engineer confirmed that the device works according to its specification. Visual inspection has been performed by the responsible leica field service engineer and the specification developer based on pictures. In addition, the user manual of the m844 c40 surgical microscope, the drawing, relevant processes and its specification of the affected part (video control unit (vcu) holder) have been reviewed by the specification developer. According to the investigation results it was found that the user injury was caused by an user/human error due to careless behavior. In addition, it was found that the laceration on his head was caused by the vcu holder which consists of a thin metal pate that is sharp-edged as per its design. Therefore an elastic band will be added to this part as an edge protection. Consequently the design change and its appropriate processes have been implemented to prevent such incidents from recurrence. Additionally the warnings of the user manual will be updated accordingly. Based on a review of the complaint statistic the probability of occurrence is remote.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003974370-2016-00007 |
| MDR Report Key | 5728288 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2016-06-16 |
| Date of Report | 2016-06-06 |
| Date of Event | 2016-05-31 |
| Date Mfgr Received | 2016-06-06 |
| Device Manufacturer Date | 2007-09-28 |
| Date Added to Maude | 2016-06-16 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 M844 C40 |
| Product Code | EPT |
| Date Received | 2016-06-16 |
| Model Number | M844 C40 |
| 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 | 1. Other | 2016-06-16 |