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

Model Number	2762-01-0004
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The light was requested to be returned.Additional information was also requested.Investigation is pending until more information can be received.
Event or Problem Description
Information was received from a health care professional via a manufacturer representative regarding a light source used for spinal surgery.Pre-op diagnosis was extensive spinal canal stenosis, degenerative scoliosis.Revision surgery performed due to relapse of symptom after initial decompression.It was reported that intra-operatively, sparks came out twice from the tip of the light source in the surgical field.There were no patient symptoms or complications as a result of this event.There was no treatment or additional surgery performed as a result of this event.There was no delay in overall procedure time.Additional information received from manufacturer representative reported that the sparks occurred twice on one side.Timing of the first spark and the operation immediately before: surgeon was operating with an electric cautery.Timing of the second spark and the operation immediately before: surgeon was operating with an electric cautery.The physician had confirmed that there was no injury such as burns or discoloration in the patient's surgical field due to sparks.There was also no health damage to the surgeon.As a supplement, after the second spark, surgeon removed it immediately considering that the product was battery powered and replaced it with a new one.The product was kept in a clean bag as it was from the clean table, and when touched the tip, only the tip on the side where the spark came out had heat.Surgeon stuck a curing tape to the reported product so that they can know that side.The patient has a history of surgery, but there is no history of disorder to be noted specially.There was also no infection.Additional information received from manufacturer representative reported that the product did not touch the patient directly, but since it is a product uses inside the body, they put the tip inside the body.Procedure performed was anterior lumbar fusion.
Additional Manufacturer Narrative
The customer did not return the product.The manufacturer reached out to a qualified electrical testing laboratory.There was not enough information from the event to adequately test a scintillant surgical light of the same model to the same conditions experienced by the device in the event.The scintillant surgical light was previously tested and met acceptance criteria for all applicable medical electrical requirements in the iec 60601 standard.The testing continues to be reviewed and updated when needed when revisions or amendments are released for the applicable iec 60601-1 and iec 60601-1-2 standards.
Event or Problem Description
Information was received from a health care professional via a manufacturer representative regarding a light source used for spinal surgery.Pre-op diagnosis was extensive spinal canal stenosis, degenerative scoliosis.Revision surgery performed due to relapse of symptom after initial decompression.It was reported that intra-operatively, sparks came out twice from the tip of the light source in the surgical field.There were no patient symptoms or complications as a result of this event.There was no treatment or additional surgery performed as a result of this event.There was no delay in overall procedure time.Additional information received from manufacturer representative reported that the sparks occurred twice on one side.Timing of the first spark and the operation immediately before: surgeon was operating with an electric cautery.Timing of the second spark and the operation immediately before: surgeon was operating with an electric cautery.The physician had confirmed that there was no injury such as burns or discoloration in the patient's surgical field due to sparks.There was also no health damage to the surgeon.As a supplement, after the second spark, surgeon removed it immediately considering that the product was battery-powered and replaced it with a new one.The product was kept in a clean bag as it was from the clean table, and when touched the tip, only the tip on the side where the spark came out had heat.Surgeon stuck a curing tape to the reported product so that they can know that side.The patient has a history of surgery, but there is no history of disorder to be noted specially.There was also no infection.Additional information received from manufacturer representative reported that the product did not touch the patient directly, but since it is a product uses inside the body, they put the tip inside the body.Procedure performed was anterior lumbar fusion.

• 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
• Manufacturer Contact: eric tarnowski ; 85 industrial drive; phillipsburg, NJ 08865 ; 9083299123
• MDR Report Key: 13177596
• Report Number: 3005977121-2022-00001
• Device Sequence Number: 4654107
• Product Code: FTD
• UDI-Device Identifier: 10865082000150
• UDI-Public: (01)10865082000150(17)240528(10)11251
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2022

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: 05/28/2024
• Device Model Number: 2762-01-0004
• Device Catalogue Number: 2762-01-0004
• Device Lot Number: 11251
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2021
• Supplement Date Received by Manufacturer: 12/08/2021
• Initial Report FDA Received Date: 01/06/2022
• Supplement Report FDA Received Date: 02/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2021
• 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