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 Problems Partial thickness (Second Degree) Burn (2694); 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"; a surgeon got a burn in the calf after holding the dyonics 300xl, 300-w bulb against his calf for 45 seconds, there was appearance of blisters.The surgeon's outcome and how the burn was treated are 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 and according to what was reported, it was determined the device contributed to the reported event.The complaint was confirmed, and the root cause was associated with intentional misuse.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.The literature article was reviewed and our clinical investigation concluded: a clinical medical evaluation found the root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded.The images provided in the article have been interpreted within the text; therefore, no further analysis of the 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.

Manufacturer Narrative

H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation.This case was reported from a literature review article.It was determined the device contributed to the reported event.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.The instructions for use were 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.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A clinical review found the root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded.However, per the article, the surgeon was burned after holding the illuminated end of the light cable to his calf in multiple spots in an experiment to learn more about the cause of the full-thickness burn a patient received from the illuminated arthroscopic light.The images provided in the article have been interpreted within the text; therefore, no further analysis of the images is required.The root cause has been associated with sabotage or intentional misuse.Factors that could have contributed to the failure include intentionally misusing the device.No containment or corrective actions are recommended at this time.

• 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: 13995747
• MDR Text Key: 288492382
• Report Number: 1643264-2022-00111
• 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,Followup
• Report Date: 05/06/2024

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; 04/30/2024
• Supplement Dates FDA Received: 05/31/2022; 05/06/2024
• 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): Required Intervention; Other