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 Type  malfunction  

Manufacturer Narrative

Submit date: 06/07/2016.An investigation is currently under way.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 new lite glove is smaller than older one.They sometimes rip at the side while pulling over the op lamp.It was noticed when pushing the lite glove above the lite handle.No person injured.Noticed before patient was in operating room.

Manufacturer Narrative

Submit date: 07/25/2016.A review of the device history record (dhr) could not be performed or date of manufacture identified as the lot number was not provided.All dhr¿s are reviewed for quality inspections and parameter compliance prior to releasing the product for distribution.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 92173 ; MX 92173
• Manufacturer (Section G): COVIDIEN; calle 9 sur no. 125 cuidad; industrial; tijuana 92173 ; MX 92173
• Manufacturer Contact: matt amaral ; 15 hampshire street; mansfield, MA 02048 ; 2034926373
• MDR Report Key: 5703115
• MDR Text Key: 46856601
• Report Number: 9612030-2016-00276
• Device Sequence Number: 1
• Product Code: FMC
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 06/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 31140257
• Device Catalogue Number: 31140257
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/25/2016
• 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