MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE TUBE SYSTEM LIGHT CABLE; LIGHT, SURGICAL, FIBEROPTIC

Model Number	4221110
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, the light cable was removed from the tube and placed on the table for an undetermined length of time.When the cable was removed from the table, it was identified that a small hole had burned through the drape where the distal end of the light cable had been.There was no reported patient impact as a result of the event.
Additional Manufacturer Narrative
The reported event was unable to be confirmed due to limited information received from the customer.No device was returned to nuvasive for evaluation; further, operative notes were not provided for review of usage/technique.It was unknown if the light source had been turned off prior to placement of the cable on the table.A review of device manufacturing records was performed and no discrepancies were found.A definitive root cause was unable to be determined with the information provided but is likely the result of unintended user error as the cable was placed on a table for an undetermined length of time and the instructions for use warn the end may be hot after use.Labeling review: warnings, cautions and precautions: safety precautions must always be exercised when using electrical equipment to prevent operator/patient shock, fire hazard, or equipment damage.Fire hazard: do not drape or cover the light source or the maxcess and/or nts light cable while it is operating.Do not place the light cable on the drape while it is operating.Light sources use high intensity lamps, which produce heat as well as brilliant light.The high brightness produced by the light source and the light output of the light cable can cause serious burns.Do not place the cable end fitting on a drape while it is operating.Take precautions to not place and rest a hot cable end fitting and/or head light on a patient or allow the system to come in contact with un-protected hands or tissue.The entire system should be allowed to cool following use.Failure to do so can cause burns and/or tissue damage.Light source end of maxcess and/or nts light cable may be hot after an extended period of use.Intra-operative warnings: the light source should be turned off when the light cables are removed from the retractor to prevent damage to the surgical drape.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: NUVASIVE TUBE SYSTEM LIGHT CABLE
• Common Device Name: LIGHT, SURGICAL, FIBEROPTIC
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 15220903
• Report Number: 2031966-2022-00146
• Device Sequence Number: 20513510
• Product Code: FST
• UDI-Device Identifier: 00195377048752
• UDI-Public: 195377048752
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K042034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/12/2022

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: 07/19/2026
• Device Model Number: 4221110
• Device Catalogue Number: N/A
• Device Lot Number: BE4275
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2022
• Initial Report FDA Received Date: 08/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose