MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-26 for SURGICAL CLIPPER, CHARGING BASE CAH4414 manufactured by Jiangsu Better Electric.
[138122178]
Based on the supplier investigation, the device history record review did not indicate any exception that could lead to the reported incident. The device master record was also checked and there have been no changes since product launch. All units were under 100% in-process system burn-in with 48 hours to screen out workmanship problems and premature defects and the records indicated no deviation. No sample was returned for investigation, only pictures of the sample were provided. Based on the investigation, the root cause could not be determined. If the device becomes available for evaluation the complaint investigation will be reopened. No action will be taken at this time, but we will continue to monitor the trend of this type of incident.
Patient Sequence No: 1, Text Type: N, H10
[138122179]
A nurse noticed a burned smell and realized that one cah4414 was starting to get on fire. No injury but customer is very concerned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423537-2019-00275 |
| MDR Report Key | 8371795 |
| Date Received | 2019-02-26 |
| Date of Report | 2019-04-26 |
| Date of Event | 2019-01-30 |
| Date Facility Aware | 2019-01-31 |
| Date Mfgr Received | 2019-01-31 |
| Date Added to Maude | 2019-02-26 |
| 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 | PATRICIA TUCKER |
| Manufacturer Street | 3651 BIRCHWOOD DR. |
| Manufacturer City | WAUKEGAN IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8478874151 |
| Manufacturer G1 | JIANGSU BETTER ELECTRIC |
| Manufacturer Street | 11 HUI HAI RD. BIN HAI ZONE, QI DONG |
| Manufacturer City | JIANG SU 226200 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 226200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SURGICAL CLIPPER, CHARGING BASE |
| Generic Name | RAZOR, SURGICAL |
| Product Code | LWK |
| Date Received | 2019-02-26 |
| Model Number | CAH4414 |
| Catalog Number | CAH4414 |
| Lot Number | 1424-1323 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JIANGSU BETTER ELECTRIC |
| Manufacturer Address | 11 HUI HAI RD. BIN HAI ZONE, QI DONG JIANG SU 226200 CH 226200 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-26 |