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 Known Impact Or Consequence To Patient (2692)
Date of Event	06/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
From the device history record, lot number 1424-2552 was manufactured in february 2014 and lot number 1806-275 was manufactured february 2018.No exceptions were recorded in the device history records that could lead to the reported incident.Two devices were returned for visual inspection, function testing and printed circuit board assembly (pcba) analysis.The sample for lot number 1424-2552, the charger base appears burnt.After peeling off the silicone, the appearance of pcba was checked and burn trace was found.They charged the base and found the charger was non-functional.The sample with lot number 1806-275, we confirmed the charger was functional.According to jiangsu better, there was no design change since the product launch.All units were under 100% in-process system burn-in with 48 hours to screen out workmanship problems and defects, there were no deviations found in the records.The complaint sample with lot number 1424-2552 was shipped in 2014, the warranty is good for 90 days.As the power supply chip has a limited life span, it had failed after extended usage which in turn resulted in the resistor/regulator (r1) overheating.At this time no corrective action will be taken we will continue to monitor the complaints for any unfavorable trends, which might require further investigation and action plan.
Event or Problem Description
Based on the information gathered from the customer the surgical clipper charging base nearly caught on fire in the operating room.The unit reportedly has a smoke stain on it and the or smelled like smoke for several hours.

• Brand Name: SURGICAL CLIPPER, CHARGING BASE
• Common Device Name: RAZOR, SURGICAL
• Manufacturer (Section D): JIANGSU BETTER ELECTRIC; 11 hui hai rd. bin hai zone,; qi dong; jiang su 22620 0; CH 226200
• MDR Report Key: 8739378
• Report Number: 1423537-2019-00328
• Device Sequence Number: 16479235
• Product Code: LWK
• UDI-Device Identifier: 00885380048015
• UDI-Public: 00885380048015
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• 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): 06/27/2019

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: 1424-2552 &1806-275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Distributor Facility Aware Date: 06/04/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/27/2019
• Patient Sequence Number: 1