MAUDE Adverse Event Report: COVIDIEN LP FOOTSWITCH; ES ACCESSORY

Model Number E6009

Device Problem Device Remains Activated (1525)

Patient Problem No Patient Involvement (2645)

Event Date 08/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date of initial report: (b)(6) 2016.To date, the incident sample has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.

Event Description

The customer reported that while the doctor was using the foot pedal, the pedal became stuck in the on position.There was no patient present.

Manufacturer Narrative

Covidien reference#: (b)(4).Date of initial report: 08/29/2016.Date of follow-up report: 10/26/2016.Evaluation of the incident device found it to function normally and within specifications.No conditions were identified that would have caused or contributed to the reported event.

• Brand Name: FOOTSWITCH
• Type of Device: ES ACCESSORY
• Manufacturer (Section D): COVIDIEN LP; 5920 longbow drive; boulder CO 80301
• Manufacturer Contact: sharon murphy ; 5920 longbow drive; boulder, CO 80301 ; 2034925267
• MDR Report Key: 5910770
• MDR Text Key: 53385044
• Report Number: 1717344-2016-00803
• Device Sequence Number: 1
• Product Code: BWA
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: 08/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2016
• 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: 289139X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/25/2016
• 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: Reuse
• Patient Sequence Number: 1