MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNIVERSAL LIGHT GUIDE ORANGE 4MM X 10 FT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	72204921
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	12/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that after a rotator cuff surgery a patient had a horizontal 12 cm burn which could have been caused by the universal light guide and it was classified as 2nd degree.Patient current condition is unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: the device, which was used in a procedure, was not returned for evaluation.Visual inspection and functional testing could not be performed.A relationship, if any, between the device and the reported incident could not be confirmed.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture.A complaint history review found no related failures.A risk review was performed and possible failure modes related to usability have been reviewed.Instructions for use warnings state: the metal tip of the light cable may be hot when it is removed from the light source.To avoid injury during removal, grasp the cable only by the source-end versitip adaptor used to secure the cable to the light source.Failure to observe these warnings may result in burns to skin, clothing, or other material inadvertently placed in front of the light post or cable.If the product is returned in the future the complaint can be reopened and evaluated.Our quality department will continue to monitor for trends.No further investigation is required.

• Brand Name: UNIVERSAL LIGHT GUIDE ORANGE 4MM X 10 FT
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 9570094
• Report Number: 3003604053-2020-00003
• Device Sequence Number: 16266345
• Product Code: GCJ
• UDI-Device Identifier: 00885556643709
• UDI-Public: 00885556643709
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K914919
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 72204921
• Device Catalogue Number: 72204921
• Device Lot Number: 126466
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 03/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR