MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LAMP MODULE, 300XL XENON; NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)

Catalog Number	7207398
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/25/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgery the light source automatically switches off during the procedure, after a small amount of time with the unit off they removed the module to find some burn marks had occurred.Light hours used: well under 500 haven't checked specifically as worried something else may occur.It is unknown if there was a backup device available.
Event or Problem Description
It was reported that during the surgery the light source automatically switched off during the procedure causing a complete loss of image.After a small amount of time with the unit off, they removed the module to find some burn marks that could have occurred on the device.A backup device was available to complete the procedure with no patient injuries.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The device was received for evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection was performed on the product and no issue was observed.Complaint of light output failure could not be reproduced.Product passed functional testing and 4 hour burn-in.No loss of light output occurred during burn-in.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.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
The reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.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 relationship, if any, between the subject device and the reported event could not be determined.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: LAMP MODULE, 300XL XENON
• Common Device Name: NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• MDR Report Key: 8904310
• Report Number: 1643264-2019-00541
• Device Sequence Number: 16206654
• Product Code: EOB
• UDI-Device Identifier: 03596010427403
• UDI-Public: 03596010427403
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K970247
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/27/2019

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: 7207398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2019
• Initial Date Received by Manufacturer: 07/26/2019
• Supplement Date Received by Manufacturer: 09/24/2019; 11/26/2019
• Initial Report FDA Received Date: 08/17/2019
• Supplement Report FDA Received Date: 09/25/2019; 11/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1