MAUDE Adverse Event Report: COVIDIEN NS-3600-B LITE GLOVE 1000/CASE

Model Number 571711

Device Problem Torn Material (3024)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

It was reported to covidien on 05/05/2016 that a customer had an issue with a lite glove.The customer states that the light handle cover is torn and could not be used.

Manufacturer Narrative

Submit date: 07/19/2016.The lot number was provided and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.Sample analysis was performed using the pictures provided by the customer, the reported issue was confirmed; the pictures show the lite glove ripped on the section of the handle.A corrective and preventative action (capa) has been opened to determine the root cause of this reported event.When root cause(s) is determined the appropriate actions will be taken to address the reported condition.If additional information is received this complaint will be reopened.This complaint will be used for tracking and trending purposes.

• Brand Name: NS-3600-B LITE GLOVE 1000/CASE
• Type of Device: LITE GLOVE
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad; industrial; tijuana ; MX
• Manufacturer (Section G): COVIDIEN; calle 9 sur no. 125 cuidad; industrial; tijuana ; MX
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5660972
• MDR Text Key: 46571598
• Report Number: 9612030-2016-00228
• Device Sequence Number: 1
• Product Code: MMP
• Combination Product (y/n): N
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 571711
• Device Catalogue Number: 571711
• Device Lot Number: 5238103764X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1