MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNIVERSAL LIGHT GUIDE ORANGE 5MM X 12 FT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	72204925
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the "light guide orange (5mm x 12ft)" had a dark substance around the connection point.The customer discussed the instructions for use and confirmed they using correctly 270°, 4 minutes, 30 cool down.No case reported; therefore, there was no patient involvement.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
D4: lot number updated.H3, h6: the reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection revealed a brown residue at the source end and residue and corrosion on the instrument end.Analysis of the customer provided images also revealed brown residue near the ferrule of various light guides and debris.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was a repeat issue.The complaint was confirmed and the root cause has been associated with a component failure.Factors that could have contributed to the reported event include chemicals or sterilization methods used for reprocessing.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.
Additional Manufacturer Narrative
H11: d4: expiration date corrected.H4: device manufacture date corrected.

• Brand Name: UNIVERSAL LIGHT GUIDE ORANGE 5MM X 12 FT
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 11096149
• Report Number: 3003604053-2020-00177
• Device Sequence Number: 630877
• Product Code: GCJ
• UDI-Device Identifier: 00885556643747
• UDI-Public: 00885556643747
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K914919
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/12/2021

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 Model Number: 72204925
• Device Catalogue Number: 72204925
• Device Lot Number: 143495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 02/05/2021; 02/05/2021
• Initial Report FDA Received Date: 12/30/2020
• Supplement Report FDA Received Date: 02/12/2021; 02/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1