MAUDE Adverse Event Report: BIHLERMED, LLC BIHLERMED 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	11/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The original notification indicated that the device was discarded by the customer and therefore could not be returned.A picture of the device was requested by bihlermed and provided on (b)(6) 2024.The picture shows that the lens is missing from one tip of a dual straight tip (2762-01-0004).There appears to be damage, a dark spot on left side, to the led and some discoloration of the metal in the same region, but it is unclear if this damage could have lead to the lens dislodgement.It is also unclear on what caused the original damage.
Event or Problem Description
It was reported that the lens tip of the surgical light was missing after the surgery.There were no further complications reported regarding the event.

• Brand Name: BIHLERMED SURGICAL LIGHT
• Common Device Name: SURGICAL LAMP
• Manufacturer (Section D): BIHLERMED, LLC; 85 industrial drive; phillipsburg NJ 08865
• Manufacturer Contact: eric tarnowski ; industrial drive; phillipsburg, NJ 08865 ; 9083299123
• MDR Report Key: 20880800
• Report Number: 3005977121-2024-00002
• Device Sequence Number: 13022497
• Product Code: FTD
• UDI-Device Identifier: 10865082000150
• UDI-Public: 10865082000150
• 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): 12/09/2024

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 Model Number: 2762-01-0004
• Device Catalogue Number: 2762-01-0004
• Device Lot Number: 12177
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2024
• 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