MAUDE Adverse Event Report: COVIDIEN LP UNKNOWN FOOTSWITCH

Model Number UNKNOWN FOOTSWI

Device Problem Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The return of the incident device has been requested.To date, it has not been received for evaluation.Additional questions in regard to the incident have been asked.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 one of their covidien footswitches is sticking.No patient injury occurred.

• Brand Name: UNKNOWN FOOTSWITCH
• Type of Device: UNKNOWN FOOTSWITCH
• 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: 5082319
• MDR Text Key: 26258664
• Report Number: 1717344-2015-00636
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Report Date: 08/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN FOOTSWI
• Device Catalogue Number: UNKNOWN FOOTSWI
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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