MAUDE Adverse Event Report: JIANGSU BETTER ELECTRIC SURGICAL CLIPPER, CHARGING BASE; RAZOR, SURGICAL

Model Number	CAH4414
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the supplier investigation the device history record review did not indicate any exception that could lead to the reported incident.No sample was available for investigation, only a photo was provided.The supplier checked the device master record and there have been no changes since product launch.All units go through 100% in-process system burn-in within 48 hours to screen out workmanship problems and premature defects and no abnormality was found in the record.From the investigation, the root cause could not be determined.There is no action taken at this time, but we will continue to monitor the trend of this type of incident.
Event or Problem Description
A burnt odor was coming from surgical clipper charging base so the customer stopped using it.There was no injury.

• Brand Name: SURGICAL CLIPPER, CHARGING BASE
• Common Device Name: RAZOR, SURGICAL
• Manufacturer (Section D): JIANGSU BETTER ELECTRIC; 11 hui hai rd. bin hai zone, q; jiang su 22620 0; CH 226200
• MDR Report Key: 8480358
• Report Number: 1423537-2019-00301
• Device Sequence Number: 13707999
• Product Code: LWK
• UDI-Device Identifier: 00885380048015
• UDI-Public: 00885380048015
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: CAH4414
• Device Catalogue Number: CAH4414
• Device Lot Number: 1424-1377
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/14/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/03/2019
• Patient Sequence Number: 1