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

Model Number	2762-01-0004
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The light was requested to be returned.Pictures and additional information was also requested.Investigation is pending until more information can be received.Report was not submitted within the 30 day deadline due to technical challenges with webtrader.
Event or Problem Description
It was reported that the lens of the surgical light broke off.There was no patient involved with the event.
Event or Problem Description
It was reported that the lens of the surgical light broke off.There was no patient involved with the event.
Additional Manufacturer Narrative
The product was received back on 10/06/21.The one end of the stainless steel light tip was deformed and flattened against the led.It was confirmed that the clear lens was no longer attached.During assembly, the lens is secured to the stainless steel tube in a manual hand fixture for swaging.This step is 100% visually inspected.The dual tip lights are packaged in a plastic tray with a retainer component to add further protection to the device in transport.The device is intended to be used with a medtronic retractor and should not be subjected to the type of force that would result in the found deformation.Warning #4 in the ifu states that "excessive force on the wires and light tips could cause the device to malfunction.Care should be taken when handling the device and manipulating the tips into the desired locations." engineering has concluded user error or misuse led to the malfunction.

• Brand Name: SCINTILLANT SURGICAL LIGHT
• Common Device Name: SURGICAL LIGHT
• Manufacturer (Section D): ENGINEERED MEDICAL SOLUTIONS CO. LLC DBA BIHLERMED; 85 industrial drive; phillipsburg NJ 08865
• MDR Report Key: 12260056
• Report Number: 3005977121-2021-00001
• Device Sequence Number: 11897734
• Product Code: FTD
• UDI-Device Identifier: 10865082000150
• UDI-Public: (01)10865082000150(17)240328(10)11211
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K133425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2021

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: 03/28/2024
• Device Model Number: 2762-01-0004
• Device Catalogue Number: 2762-01-0004
• Device Lot Number: 11211
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/29/2021
• Supplement Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 08/02/2021
• Supplement Report FDA Received Date: 10/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1