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	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/06/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a procedure, the universal light guide's cable broke.There was no backup device available.No delay or patient injury was reported.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 not 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 dhr review was performed and showed no non-conformances or deviations associated with the lot number provided.A review of the complaint history records for the listed part revealed no prior complaints for the listed for this lot number.Factors that are known to contribute to the alleged fault/failure may include mishandling during shipping, use or reuse of the device, contact with another source, or wear and tear over time.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.If the product is returned in the future the complaint can be re-opened and evaluated.

• 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: 9413438
• Report Number: 3003604053-2019-00143
• Device Sequence Number: 4220774
• 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: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2020

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: 141207
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 12/30/2019
• Initial Report FDA Received Date: 12/04/2019
• Supplement Report FDA Received Date: 01/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1