MAUDE Adverse Event Report: COVIDIEN LITE GLOVE

Model Number LT-F01B

Device Problem Component Falling (1105)

Patient Problem No Information (3190)

Event Date 08/08/2017

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.Several 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

The customer reports the light covers were falling off of the light handles.

Manufacturer Narrative

For additional information received from the customer regarding the product event.One sample was received and a visual inspection and functional test were performed and the reported issue was not confirmed.The lot number was provided and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.This complaint will be considered as unconfirmed.A root cause could not be determined as it was unknown which adapter model was used during the procedure.For all lots produced, the supplier performs incoming inspection and verifies that the material meets retention and installation force acceptance criteria.As part of continuous improvement efforts and a corrective action, the supplier changed the inspection measurement technique from go / no go gauging to using a pulling / insert force test.Quality will continue to monitor this issue through incoming inspection and complaints.If additional information is received, the investigation will resume as needed.This complaint will be used for trending purposes.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reports that a patient was in the room when the lite glove fell off.The fallen glove was taken off of the patient and a new glove was placed.The customer further reports that there was no patient injury or medical intervention reported.

• Brand Name: LITE GLOVE
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6849805
• MDR Text Key: 85597412
• Report Number: 1282497-2017-05336
• Device Sequence Number: 1
• Product Code: FTA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LT-F01B
• Device Catalogue Number: LT-F01B
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1