MAUDE Adverse Event Report: COVIDIEN DEVON LITE GLOVE LIGHT HANDLE SYSTEMS; COVER, BARRIER, PROTECTIVE

Catalog Number 31140257

Device Problem Packaging Problem (3007)

Patient Problem Test Result (2695)

Event Date 08/03/2015

Event Type  malfunction  

Event Description

Current packaging curls the side of the light handles.Light handles do not flatten out while in use.This results in an incomplete covering of the non sterile handle which could cause contamination of the surgical team during the surgical case.The packaging problem is present in multiple lots with multiple devices.

• Brand Name: DEVON LITE GLOVE LIGHT HANDLE SYSTEMS
• Type of Device: COVER, BARRIER, PROTECTIVE
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 5010309
• MDR Text Key: 23255408
• Report Number: 5010309
• Device Sequence Number: 1
• Product Code: MMP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Report Date: 08/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 06/20/2018
• Device Catalogue Number: 31140257
• Device Lot Number: 5153101664X
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/03/2015
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 08/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1