MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-25 for INTEGRATED DIGITAL SURGICAL RACK manufactured by Black Diamond Video.
[115281847]
A steris service technician arrived onsite following the reported event. The technician inspected the integrated digital surgical rack and identified charring and evidence of smoke damage inside the unit; however, the technician was unable to identify the root cause of the reported event. The unit was removed from service and returned to steris for further evaluation. Investigation in process. A follow-up mdr will be submitted when additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[115281848]
The user facility reported smoke was emitting from their integrated digital surgical rack. Procedural cancellations occurred as the facility was evacuated. No report of injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008776287-2018-00003 |
| MDR Report Key | 7720401 |
| Date Received | 2018-07-25 |
| Date of Report | 2018-07-25 |
| Date of Event | 2018-06-21 |
| Date Mfgr Received | 2018-06-25 |
| Date Added to Maude | 2018-07-25 |
| 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. DANIEL DAVY |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927453 |
| Manufacturer G1 | BLACK DIAMOND VIDEO |
| Manufacturer Street | 503 CANAL BLVD. |
| Manufacturer City | RICHMOND CA 94804 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94804 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | INTEGRATED DIGITAL SURGICAL RACK |
| Generic Name | INTEGRATED DIGITAL SURGICAL RACK |
| Product Code | FWC |
| Date Received | 2018-07-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BLACK DIAMOND VIDEO |
| Manufacturer Address | 503 CANAL BLVD. RICHMOND CA 94804 US 94804 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-25 |