MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN VISUALIZATION SYSTEM DEVICE; IMAGE, ILLUMINATION, FIBEROPTIC, FOR ENDOSCOPE

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 03/06/2020

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).Chitnavis, j.(2020).Silent burn: the hidden danger and effects of bright light from fibre-optic cables in arthroscopic knee surgery.Journal of surgical case reports, 2020(4), rjaa068.

Event Description

It was reported that on the literature review "silent burn: the hidden danger and effects of bright light from fiber-optic cables in arthroscopic knee surgery"; 1 patient got a burn in the left thigh after a procedure using a dyonics 300xl, 300-w bulb.The burn was managed with non-operative treatment.The patient outcome is unknown.No further information is available.

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.This case was reported from a literature review article.It was determined the device contributed to the reported event.The complaint was confirmed, and the root cause was associated with a failure to follow instructions.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.This includes the following two warnings.During operation, avoid prolonged contact of scope tip to patient tissue or flammable materials.Scope tip may reach high temperatures due to high-intensity light transmission.Do not leave the operating light cord on a patient or the drapes.Failure to observe this precaution may result in burns to the patient and/or the surrounding drapes.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.A complaint history review for product family found no similar reported events.A risk management review for product family found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A clinical medical evaluation found no conclusions can be made from this publication as its limited to the information provided and further investigation is not possible.In addition, the surgeon/author provided an analysis of all the attached images.Therefore, no further interpretation of the attached images is required.No further clinical assessment is warranted at this time.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: UNKNOWN VISUALIZATION SYSTEM DEVICE
• Type of Device: 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: 13995592
• MDR Text Key: 288494203
• Report Number: 1643264-2022-00110
• Device Sequence Number: 1
• Product Code: FFS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K994084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2022
• Initial Date FDA Received: 04/04/2022
• Supplement Dates Manufacturer Received: 05/06/2022
• Supplement Dates FDA Received: 05/31/2022
• 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
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 23 YR