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

Model Number	E6009
Medical Device Problem Codes	Device Remains Activated (1525); Component Missing (2306)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample was requested but to date has not been received for evaluation.If the sample or additional information pertinent to the incident is obtained, a follow-up report will be submitted.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported that the device was causing the generator to continuously activate.There is no patient injury associated with this issue.
Additional Manufacturer Narrative
Device evaluation one unit was returned for evaluation.The returned sample did not meet specification as received.A visual inspection found the device was missing a spring.The investigation confirmed the reported condition.The investigation found that the bipolar foot pedal was missing a spring which was causing a continuous activation on the bipolar foot pedal and lead to the issue with the other ports not activating.The investigation isolated the failure to the missing spring on the bipolar footswitch, but a root cause was not identified.If information is provided in the future, a supplemental report will be issued.

• 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: 6945500
• Report Number: 1717344-2017-06046
• Device Sequence Number: 11064961
• Product Code: BWA
• UDI-Device Identifier: 10884524000381
• UDI-Public: 10884524000381
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2017

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: E6009
• Device Catalogue Number: E6009
• Device Lot Number: 243327X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/15/2017
• Supplement Date Received by Manufacturer: 10/26/2017
• Initial Report FDA Received Date: 10/12/2017
• Supplement Report FDA Received Date: 11/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1