MAUDE Adverse Event Report: JIANGSU BETTER ELECTRIC COMPANY BLADE, SURGICAL CLIPPER, STANDARD PREP

Model Number CAH4406D

Device Problem Sharp/jagged/rough/etched/scratched (2594)

Patient Problem Nicks, cuts or tears of dura or other tissues by device (1417)

Event Date 01/29/2015

Event Type  malfunction  

Event Description

A patients skin appeared to get caught in the blade causing more than a small abrasion.

Manufacturer Narrative

The actual sample involved in this report is being decontaminated.Once decontaminated, it will be reviewed and a follow up report will be submitted when the investigation has been completed.

Manufacturer Narrative

The actual failed customer sample was received for evaluation on march 5, 2015.The inspection on the returned sample shows it meets all the product specifications.The device history record was reviewed for the reported lot number g1416-sh, it did not show any exception during production which could lead to the reported issue.Inspection on the blade and its teeth shows no abnormality.Cutting test on (b)(4) nylon material and sharpness test on teeth indicated that it met the specification requirements.Therefore, based on these findings we are unable to determine the root cause for the issue reported.No corrective action will be taken at this time.We will continue to monitor for any similar reports.

• Brand Name: BLADE, SURGICAL CLIPPER, STANDARD PREP
• Type of Device: BLADE, SURGICAL CLIPPER, STANDARD PREP
• Manufacturer (Section D): JIANGSU BETTER ELECTRIC COMPANY; 11 hui hai rd.; bin hai zone, qi dong; jiang su 2262 00; CH 226200
• Manufacturer (Section G): JIANGSU BETTER ELECTRIC COMPANY; 11 hui hai rd. bin hai zone,; qi dong; jiang su 2262 00; CH 226200
• Manufacturer Contact: michele donatich ; 1500 waukegan road; waukegan, IL 60085 ; 8478876412
• MDR Report Key: 4551323
• MDR Text Key: 5517575
• Report Number: 1423537-2015-00011
• Device Sequence Number: 1
• Product Code: LWK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CAH4406D
• Device Catalogue Number: CAH4406D
• Device Lot Number: G1416-SH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/26/2015
• Distributor Facility Aware Date: 01/29/2015
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 02/06/2015
• Date Manufacturer Received: 01/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR