MAUDE Adverse Event Report: ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP. FIBER OPTIC LIGHT CABLE 3.5MM X 2300MM; 7.5 FT.

Catalog Number	FOC158/175
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user facility has been repeatedly contacted to request return of the device mentioned in the report as well as additional information with regard to use of the device and the procedure being performed.The device has not been returned nor has additional information been provided.The investigation is ongoing.
Event or Problem Description
Per user facility report, during an elective facelift and bilateral removal of excessive tissue from underneath eyes, the light cord for the facelift retractor -without the handheld retractor attached- fell from the mayo stand while the light was still on 100%.The cord fell onto the drapes over the patient's abdomen resulting in a 1 mm burn hole in the drape.The patient's skin was not burned and there was no injury as a result.
Additional Manufacturer Narrative
Additional attempts were made to obtain more information with regard to the procedure, its outcome, the light source and the power setting as well as the lot# of the device, but no information has been forthcoming.The user facility was not able to identify and return the light cord since it was put back in use following the event.It has been in use at the facility for over three months since the incident occurred.The facility has indicated that multiple light cables of this type are currently in use and that no records of repairs exist, thus indicating that the light cord involved in the incident is functioning correctly.Complaint files were checked with regard to this model of fiber optic light cable.The user facility in question has been purchasing these fiber optic light cables since 2015 without incident.No complaints have been received regarding the device, neither from the user facility in question nor from any other customer, other than medwatch report 2100090000-2024-8002 that triggered the current investigation.In accordance with the event description, the retractor was removed from the cable prior to the event.It follows that or personnel was finished using the retractor and the cable, but failed to turn off the light source, causing the light cable connector to heat up unnecessarily.In addition, the cable was not adequately secured and fell on the drape covering the patient.The device instructions for use include the following warning with regard to potential heating of the light cable connector during use: "in combination with high performance light sources, the light cable connector which connects to the retractor can heat up considerably and may cause burns to the patient's or user's skin." this warning was disregarded.We conclude that the incident was due to user error.

• Brand Name: FIBER OPTIC LIGHT CABLE 3.5MM X 2300MM; 7.5 FT.
• Common Device Name: FIBER OPTIC LIGHT CABLE
• Manufacturer (Section D): ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP.; 300 shames dr.; westbury NY 11590
• Manufacturer (Section G): ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP.; 300 shames dr.; westbury NY 11590
• Manufacturer Contact: marie bonazinga ; 300 shames dr.; westbury, NY 11590 ; 5163332570
• MDR Report Key: 18865128
• Report Number: 2434839-2024-00001
• Device Sequence Number: 14287420
• Product Code: FCW
• UDI-Device Identifier: 00841645131946
• UDI-Public: 00841645131946
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2024

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 Catalogue Number: FOC158/175
• 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: 02/07/2024
• Supplement Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Race: White