MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVCE REPL LIGHT SOURCE 500XL XENON; IMAGE, ILLUMINATION, FIBEROPTIC, FOR ENDOSCOPE

Model Number	72200568S
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: case-(b)(4).
Event or Problem Description
It was reported that, during setup for a shoulder procedure, the light source powered off unexpectedly.It is unknown if there was a backup device available and there was no delay reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).The reported device, intended for use in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A relationship, if any, between the subject device and the reported event could not be determined.Factors, unrelated to the manufacturing and design of the device that could have contributed to the reported event, include poor ventilation due to external obstructions to vents or excessive dust buildup on rear fans or fan guards.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.A visual inspection was performed on the exterior of product and no physical damage was observed.Complaint of power loss could not be reproduced.Product passed functional testing and 2 hour burn-in with no faults or errors.All functions perform as expected.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.It was determined the device did not contribute to the reported event.The complaint was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.Factors, unrelated to the manufacturing and design of the device that could have contributed to the reported event, include overheating of the power supply caused by poor ventilation due to external obstructions to vents.No containment or corrective actions are recommended at this time.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.No containment or corrective actions are recommended at this time.

• Brand Name: SVCE REPL LIGHT SOURCE 500XL XENON
• Common Device Name: IMAGE, ILLUMINATION, FIBEROPTIC, FOR ENDOSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 11676182
• Report Number: 1643264-2021-01430
• Device Sequence Number: 3015547
• Product Code: FFS
• UDI-Device Identifier: 03596010650504
• UDI-Public: 03596010650504
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K994084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/06/2022

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 Model Number: 72200568S
• Device Catalogue Number: 72200568S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 05/07/2021; 05/05/2022
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 05/12/2021; 05/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown