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

Model Number 571711

Device Problem Split (2537)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 06/30/2016.An investigation is currently underway.Upon completion, the results will be forwarded.Attempts to gather information from the customer were made.To date, no response has been received.If additional pertinent information becomes available, the report will be updated.

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue with a lite glove.The customer reports that the light handle glove is splitting during the procedure.

Manufacturer Narrative

Submit date: 09/29/2016.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.Because a sample was not returned, we were unable to perform a thorough follow up investigation to include functional and visual evaluations to confirm the reported issue and root cause analysis.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; tullamore 22500 ; MX 22500
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5761361
• MDR Text Key: 49281126
• Report Number: 9612030-2016-00301
• Device Sequence Number: 1
• Product Code: LZC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2016
• 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: 5341104364X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1