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

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	09/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The light could not be requested back because it was discarded.Follow up questions were asked to the complainant to clarify how the light was used during the procedure.Responses were received on 10/07/22, but the responses did not include pictures and did not help with the investigation.The dhr was reviewed for lot 11440.No indications leading to an insecure lens were found.Without pictures or a device to examine it is not possible to determine the exact cause of lens dislodgement.It should also not be possible to reattach a lens once disconnected.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 (b)(4).
Event or Problem Description
Information was received from healthcare provider via the distributor regarding a patient having spinal therapy for an indication of l4 compression.It was reported that the device was installed in a retractor and prepared for use.However, the device was removed prior to use and the lens at the tip of the light came off.The complainant stated that the lens could be reattached, but did not use the device after reattaching the lens in case it dislocated again.There were no patient symptoms reported.There were no further complications reported regarding the event.

• 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: 15594711
• Report Number: 3005977121-2022-00002
• Device Sequence Number: 19392300
• Product Code: FTD
• UDI-Device Identifier: 10865082000150
• UDI-Public: (01)10865082000150(17)250128(10)11440
• 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
• Report Date (Section B): 10/13/2022

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: 01/28/2025
• Device Model Number: 2762-01-0004
• Device Catalogue Number: 2762-01-0004
• Device Lot Number: 11440
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2022
• Initial Report FDA Received Date: 10/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2022
• 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