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

Model Number	2658-01-0002
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/18/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: SURGICAL LIGHT
• Manufacturer (Section D): ENGINEERED MEDICAL SOLUTIONS CO. LLC; 85 industrial dr.; phillipsburg NJ 08865
• MDR Report Key: 7566660
• Report Number: 3005977121-2018-00001
• Device Sequence Number: 167357
• Product Code: FTD
• UDI-Device Identifier: 10865082000129
• UDI-Public: (01)10865082000129(17)210228(10)10477
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K071180
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/18/2018

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
• Operator of Device: 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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2018
• Initial Report FDA Received Date: 06/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1