MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-27 for DYND70800 manufactured by Medline Industries Inc..
[74073745]
Facility representative stated that a clipper smoked and was charred. Clipper was sitting in the charging base in the cath lab when staff noticed small spark and smoke coming from the charger base. A nurse unplugged the charger base and this stopped the smoking, no fire occurred. No procedures were affected due to this incident. The clipper and base have been in use for approximately three years. No staff or patient was injured and no medical intervention was required. Sample was returned and it was determined that the device was part of a corrective action that took place in 2015. It is unknown why the facility was using the recalled device. We have followed up with them to assure they do not continue to use any recalled devices. Due to the reported incident and in an abundance of caution this medwatch is being filed.
Patient Sequence No: 1, Text Type: N, H10
[74073746]
It was reported that the surgical clipper charge base smoked.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2017-00026 |
| MDR Report Key | 6525628 |
| Date Received | 2017-04-27 |
| Date of Report | 2017-07-27 |
| Date Mfgr Received | 2017-04-13 |
| Device Manufacturer Date | 2013-11-01 |
| Date Added to Maude | 2017-04-27 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. MEGAN DEBUS |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Manufacturer Phone | 8477703962 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | SURGICAL CLIPPER CHARGER BASE |
| Product Code | LWK |
| Date Received | 2017-04-27 |
| Catalog Number | DYND70800 |
| Lot Number | 13K1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-04-27 |