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

Catalog Number 72200568SR

Device Problem Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that xenon light source's fan was not working.No case reported; therefore, there was no patient involvement.Results of investigation revealed an e12 temperature error which makes it a reportable event.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H11: corrected information on b5 (describe event or problem).H10: the reported device, intended for use in treatment, was received for evaluation.A visual inspection was performed on the exterior of product and no physical damage was observed.There was no relationship found between the returned device and the reported incident.The complaint of damaged/broken component could not be confirmed.Light source did fail for e-12 errors caused by an electronic component failure.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.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 found related failures; this failure mode will be trended to assess for any necessary corrective actions.No containment or corrective actions are recommended at this time.

Event Description

It was reported that xenon light source's fan was not working.No case reported; therefore, there was no patient involvement.Results of investigation revealed an e12 temperature error which makes it a reportable event.

• Brand Name: SVCE REPL {} LIGHT SCE {} 500XL {} XENON
• Type of Device: IMAGE, ILLUMINATION, FIBEROPTIC, FOR ENDOSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 10153576
• MDR Text Key: 195527883
• Report Number: 1643264-2020-00384
• Device Sequence Number: 1
• Product Code: FFS
• Combination Product (y/n): N
• PMA/PMN Number: K994084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 07/07/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 72200568SR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2020
• Initial Date Manufacturer Received: 04/06/2020
• Initial Date FDA Received: 06/15/2020
• Supplement Dates Manufacturer Received: 07/06/2020
• Supplement Dates FDA Received: 07/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1