MAUDE Adverse Event Report: COVIDIEN 3612 LITE GLOVE

Model Number 31140257

Device Problems Inadequacy of Device Shape and/or Size (1583); Torn Material (3024)

Patient Problem No Patient Involvement (2645)

Event Date 01/11/2016

Event Type  malfunction  

Manufacturer Narrative

Submit date: 2/22/2016.An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue with a lite glove.Customer reports the lite glove is too small and tore apart when placed on the lite handle.No person injured, no patient involved.The issue was noticed before patient was in op room.

Manufacturer Narrative

Submit date: 07/01/2016.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: 3612 LITE GLOVE
• 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 22500 ; MX 22500
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5450479
• MDR Text Key: 39210191
• Report Number: 9612030-2016-00073
• Device Sequence Number: 1
• Product Code: FMC
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 31140257
• Device Catalogue Number: 31140257
• Device Lot Number: 5181104564X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/16/2016
• Initial Date FDA Received: 02/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/01/2016
• 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