MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER VALLEYLAB; UNIT, ELECTROSURGICAL ANDCOAGULATION, WITH ACCESSORIES

Model Number	E6008B
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the product sample was not returned to the post market vigilance laboratory.A picture was provided by the customer for analysis.The sample did not meet specification.The reported condition was confirmed.The picture sample showed that the blue and yellow pedals were swapped in their configuration.The investigation could not determine a root cause or a probable root cause for the failure at this time.
Event or Problem Description
According to the reporter, during servicing, the device had a faulty configuration of cut and coagulation pedals, pedals were swapped in their configuration with the blue coagulation on the left and yellow cut on the right.There was no patient involvement.

• Brand Name: VALLEYLAB
• Common Device Name: UNIT, ELECTROSURGICAL ANDCOAGULATION, WITH ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 8772952
• Report Number: 1717344-2019-00869
• Device Sequence Number: 2639291
• Product Code: BWA
• UDI-Device Identifier: 10884524001647
• UDI-Public: 10884524001647
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K874794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/09/2019

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: E6008B
• Device Catalogue Number: E6008B
• Device Lot Number: 39031031X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2019
• Initial Report FDA Received Date: 07/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1