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	02/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint information has been forwarded to the supplier for investigation.Investigation results are pending at this time as the sample has not yet been received by the supplier.A followup report will be submitted once the investigation has been completed by the supplier.
Event or Problem Description
The surgical clipper charger base was overheating, was warm to the touch.No injury.
Additional Manufacturer Narrative
There was no deviation recorded in the device history record for the affected lot.Review of the returned samples confirm that the failure was due to resistor r1 being burned out.This, in turn, was found to be due to voltage regulator failure.The defective product was manufactured in 2014.The exact date of shipment to the final customer and date when the customer had put the product to use was speculated to be 6 months but cannot be confirmed.From the investigation, the result is consistent with the symptom of extended usage, resulting in the voltage regulator failure.This in turn, resulted in the overheating.At this time no additional action will be taken but we will continue to monitor the trend of this type of incident.

• 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: 8482722
• Report Number: 1423537-2019-00302
• Device Sequence Number: 1432241
• Product Code: LWK
• UDI-Device Identifier: 00885380048015
• UDI-Public: 00885380048015
• Combination Product (Y/N): N
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2019

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: Health Professional
• Device Model Number: CAH4414
• Device Catalogue Number: CAH4414
• Device Lot Number: 1427-996 AND 1427-2470
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 03/19/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2019
• Supplement Report FDA Received Date: 05/14/2019
• Patient Sequence Number: 1