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

Model Number	2762-01-0003
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	06/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The light could not be requested back because the manufacturer does not accept back contaminated devices for evaluation.Follow up questions were asked to the complainant to ask for additional information and if there were any photographs.The response received did not provide photographs or any additional information.The dhr was reviewed for lot 11541.No indications leading to an insecure lens were found.It is noted that the reporter stated that the light was continued to be used without the tip.This is against the warnings provided in the ifu.Warning #1 states "inspect the scintillant® dual tip light prior to use to ensure proper function and working condition.Do not use a device that is damaged." without pictures or a device to examine, it is not possible to determine the exact cause of lens dislodgement.During assembly, the lens is secured to the stainless steel tube in a manual hand fixture for swaging.This step is 100% visually inspected.It is not possible for this lens to be disconnected from the device without excessive force.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." in previous events where the lens was detached for this product, and pictures or a returned product was evaluated, there were signs of excessive force and misuse of the surgical light.
Event or Problem Description
Information was received from a healthcare professional via the distributor regarding a patient undergoing l2/3/4/5 olif at levels l2/3/4/5 for degenerative scoliosis.It was reported that the tip of the bent tip fell out when attempting to replace the radiance with the retractor blade after the retractor was placed on l4/5.The physician noticed it and removed it.It was used without a tip.There was no patient symptoms or complications as a result of this event.No further complications were reported/anticipated.

• Brand Name: SCINTILLANT SURGICAL LIGHT
• Common Device Name: SURGICAL LAMP
• Manufacturer (Section D): ENGINEERED MEDICAL SOLUTIONS CO. LLC DBA BIHLERMED; 85 industrial drive; phillipsburg NJ 08865
• Manufacturer Contact: eric tarnowski ; 85 industrial drive; phillipsburg, NJ 08865 ; 9083299123
• MDR Report Key: 17318248
• Report Number: 3005977121-2023-00002
• Device Sequence Number: 6226390
• Product Code: FTD
• UDI-Device Identifier: 10865082000143
• UDI-Public: 10865082000143
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 07/13/2023

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: 03/28/2025
• Device Model Number: 2762-01-0003
• Device Catalogue Number: 2762-01-0003
• Device Lot Number: 11541
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2023
• Initial Report FDA Received Date: 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown