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

Model Number 2762-01-0002

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/15/2016

Event Type  malfunction  

Manufacturer Narrative

The device was returned to the distributor, but could not be returned to engineered medical solutions because the device had been in contact with the patient.Packaging was disposed, so the exact lot number could not be determined.Distributor provided four potential lot numbers.Device history records were reviewed for these four lots with no indication of a resulting issue with the lens/tip assembly as exhibited in the images provided.Distributor provided images of the device.The stainless steel tip of the light that holds the lens had the customary lens attachment feature present, indicating correct forming/assembly of the light.The tip exhibited several large scrapes and was flattened along one side.A normally used surgical light will not display this type of damage.User error or misuse contributed to the lens being dislodged from the tip.

Event Description

A lens from the scintillant dual tip surgical light was knocked off.The lens was removed from the working area at the conclusion of the procedure with no incident or remaining pieces left in the patient.No patient complications were reported.

• Brand Name: SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT
• Type of Device: SURGICAL LIGHT
• Manufacturer (Section D): ENGINEERED MEDICAL SOLUTIONS CO. LLC; 85 industrial dr.; phillipsburg NJ 08865
• Manufacturer (Section G): 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: 6028260
• MDR Text Key: 57696631
• Report Number: 3005977121-2016-00001
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2762-01-0002
• Device Catalogue Number: 2762-01-0002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 38 YR