MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LIGHT SOURCE LED 3000; IMAGE, ILLUMINATION, FIBEROPTIC, FOR ENDOSCOPE

Catalog Number 72204011

Device Problem Optical Obstruction (3002)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/16/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during a routine inspection the light source was switching on, but there is no light output.No case was involved.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10, h3, h6: 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 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 concluded this was a repeat issue.A relationship, if any, between the subject device and the reported event could not be determined.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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

Manufacturer Narrative

Internal complaint reference: (b)(4).H10: the information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.Reassessment found that the alleged device is not a smith+nephew product.As a result, smith+nephew is not responsible for reporting according to 21 c.F.R.Part 803.3.Additionally, manufacturer has been notified of the event.If further details are provided confirming there is a sn product involved in the event, our files will be updated and the event will be reassessed accordingly.

• Brand Name: LIGHT SOURCE LED 3000
• Type of Device: IMAGE, ILLUMINATION, FIBEROPTIC, FOR ENDOSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 11626814
• MDR Text Key: 244213361
• Report Number: 3003604053-2021-00138
• Device Sequence Number: 1
• Product Code: FFS
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72204011
• Device Lot Number: 16020477
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1