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	01/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the supplier investigation, the device history record review did not indicate any exception that would have lead to the reported incident.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.As sample was not returned for further investigation, the root cause for the reported incident could not be determined.If the device becomes available for evaluation the complaint investigation will be reopened.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
The customer noticed the surgical clipper charging base was very hot.They did not want to take any chances and removed it from the department.No injury but customer was worried.
Additional Manufacturer Narrative
The charging base was returned for functional testing.The function of the charger base was tested and it functioned as intended.The device was charged for 4 hours and the temperature was 34.6°c which matched the specification and no issue of hotness occurred.From the investigation the root cause for the reported issue could not be determined.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; qi dong; jiangsu 22620 0; CH 226200
• MDR Report Key: 8377580
• Report Number: 1423537-2019-00276
• Device Sequence Number: 19237682
• 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,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: No Information
• Device Model Number: CAH4414
• Device Catalogue Number: CAH4414
• Device Lot Number: 1424-1608
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/01/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/28/2019
• Supplement Report FDA Received Date: 05/14/2019
• Patient Sequence Number: 1