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 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.
Event or Problem Description
A nurse noticed a burned smell and realized that one cah4414 was starting to get on fire.No injury but customer is very concerned.
Event or Problem Description
A nurse noticed a burning smell and realized that it was coming from the surgical clipper charging base.No injury but customer is very concerned.
Additional Manufacturer Narrative
The complaint sample was received for investigation.It was manufactured in 2014 and according to the customer they began using it in late 2016 to early 2017.Based on the that information, this product has been used for 2 years which exceeds the shelf life of 90 days.As the power supply chip has a limited life span, it failed after extended usage which in turn resulted in the r1 overheating.There is no additional action taken at this time, 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; jiang su 22620 0; CH 226200
• MDR Report Key: 8371795
• Report Number: 1423537-2019-00275
• Device Sequence Number: 1781209
• 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: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/26/2019

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: 1424-1323
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/31/2019
• Initial Date Received by Manufacturer: 01/31/2019
• Supplement Date Received by Manufacturer: 01/31/2019; 01/31/2019
• Initial Report FDA Received Date: 02/26/2019
• Supplement Report FDA Received Date: 02/27/2019; 04/26/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other