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

Model Number E6009

Device Problems Device Remains Activated (1525); Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 Description

The customer reported that the device was causing the generator to continuously activate.There is no patient injury associated with this issue.

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
• Type of Device: UNIT, ELECTROSURGICAL ANDCOAGULATION, WITH ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer Contact: sharon murphy ; 5920 longbow drive; boulder, CO 80301 ; 2034925267
• MDR Report Key: 6945500
• MDR Text Key: 89826938
• Report Number: 1717344-2017-06046
• Device Sequence Number: 1
• Product Code: BWA
• UDI-Device Identifier: 10884524000381
• UDI-Public: 10884524000381
• Combination Product (y/n): N
• Reporter Country Code: SF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E6009
• Device Catalogue Number: E6009
• Device Lot Number: 243327X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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