MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LIGHT CABLE,GEMINI,5MM X 8FT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	2140
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during an arthroscopic acl reconstruction, the patient skin burned on the lateral portion on the left calf.It is unknown if there was a delay or if a backup device was available and how the issue was resolved.
Additional Manufacturer Narrative
The device, used in treatment, 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 dhr review could not be performed because the lot number was not provided.A complaint review was performed with the part number and showed no other complaints of patient burn.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.The instructions for use were reviewed and were found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.Per ifu precautions: ¿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.¿ should the device or additional information be received, the complaint can be reopened and reevaluated.

• Brand Name: LIGHT CABLE,GEMINI,5MM X 8FT
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 9010179
• Report Number: 3003604053-2019-00119
• Device Sequence Number: 2487556
• Product Code: GCJ
• UDI-Device Identifier: 03596010103246
• UDI-Public: 03596010103246
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K914919
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2019

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 Catalogue Number: 2140
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/27/2018
• Supplement Date Received by Manufacturer: 11/06/2019
• Initial Report FDA Received Date: 09/12/2019
• Supplement Report FDA Received Date: 11/07/2019
• 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