MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNIVERSAL LIGHT GUIDE ORANGE 5MM X 10 FT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	72204924
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the universal light guide cable was damaged after passing through the sterilization process as they were found sticking and overheating.The first sterilization was made in the sterrad; the second one, made by the hospital, is unknown.As this happened prior to any case, there was not patient involvement.
Additional Manufacturer Narrative
Visual inspection and functional testing could not be performed because the device in question has not been returned for evaluation.Thus, the complaint could not be verified and a root cause could not be determined with confidence.It is difficult to perform an accurate evaluation of a failure without having the failed product to look at.As such the complaint is being closed without conclusion.However, if the product is returned in the future the complaint can be reopened and evaluated.
Additional Manufacturer Narrative
H10.H3, h6: an evaluation was performed by smith and nephew and could confirm the customer complaint for the universal light guide cable was damaged after passing through the sterilization process as it was found sticking.A visual inspection was performed and showed the orange sheathing is sticking to the sterile wrap.Correctionin g3, user facility should be marked and distributor unmarked.

• Brand Name: UNIVERSAL LIGHT GUIDE ORANGE 5MM 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: 8774298
• Report Number: 3003604053-2019-00071
• Device Sequence Number: 2666837
• Product Code: GCJ
• UDI-Device Identifier: 00885556643730
• UDI-Public: 00885556643730
• 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,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 72204924
• Device Lot Number: 127766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2019
• Initial Date Received by Manufacturer: 06/14/2019
• Supplement Date Received by Manufacturer: 08/08/2019; 10/01/2019
• Initial Report FDA Received Date: 07/09/2019
• Supplement Report FDA Received Date: 08/09/2019; 10/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1