MAUDE Adverse Event Report: ENGINEERED MEDICAL SOLUTIONS CO. LLC SCINTILLANT SURGICAL LIGHT

Model Number 2658-01-0002

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/18/2018

Event Type  malfunction  

Manufacturer Narrative

The light could not be requested back because it had been in contact with the patient.Pictures were provided.The lens appears to be intact leading to the investigators to believe that there was an issue with the adhesive.The operators who assemble the lights were interviewed and the dhr was reviewed.There was nothing that indicated anything unusual.The evaluation is inconclusive.In the eleven years these surgical light models have been on the market, this is the first incident where the lens came off.

Event Description

The lens from the surgical light fell off while in use on a patient.The lens was able to be retrieved.There was no injury, delay in surgery, or any additional procedures required.

• Brand Name: SCINTILLANT SURGICAL LIGHT
• Type of Device: SURGICAL LIGHT
• Manufacturer (Section D): ENGINEERED MEDICAL SOLUTIONS CO. LLC; 85 industrial dr.; phillipsburg NJ 08865
• Manufacturer Contact: eric tarnowski ; 85 industrial dr.; phillipsburg, NJ 08865 ; 9083299123
• MDR Report Key: 7566660
• MDR Text Key: 110471082
• Report Number: 3005977121-2018-00001
• Device Sequence Number: 1
• Product Code: FTD
• UDI-Device Identifier: 10865082000129
• UDI-Public: (01)10865082000129(17)210228(10)10477
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 2658-01-0002
• Device Catalogue Number: 2658-01-0002
• Device Lot Number: 10477
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1