MAUDE Adverse Event Report: COVIDIEN 3612 LITE GLOVE

Model Number 31140257

Device Problems Split (2537); Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Manufacturer Narrative

Submit date: 08/05/2016.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.The customer reports the light glove split when placed on the operating room light.The customer further stated that the lite glove is a little tight when placing on the handle, they have to continually (shove) it on the handle and is a little more challenging than before.The split/tear was found mostly when placing on the handle during setup.Once the split was noticed they would remove the top glove if they double glove, and if they single glove, they change the glove.The customer states that the material is really thin.A skytron aurora adapter is being used with the lite glove.

Manufacturer Narrative

Submit date: 09/29/2016.

Manufacturer Narrative

Submit date: 09/29/2016.Originally reported as ns-3600-b lite glove 1000/case and should be 3612 lite glove.Model number: originally reported as unknown or and should be 31140257.Catalog number: originally reported as unknown or and should be 31140257.Lot number: originally left blank and per the product received from the customer, the lot number is 6147100264.

• 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 ; MX
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5850318
• MDR Text Key: 52422432
• Report Number: 9612030-2016-00366
• Device Sequence Number: 1
• Product Code: LYZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/22/2016

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: 6147100264
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/22/2016
• Initial Date FDA Received: 08/05/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/29/2016; 09/29/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1