MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVCE REPL ASCOPE 1.9MM X 30; ARTHROSCOPE

Catalog Number	4184S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign post code - (b)(6).
Event or Problem Description
It was reported that, during a knee arthroscopy, the device had a damage of tip lens.There was not any back-up device available to complete the procedure.It is unknown how the procedure was finished.Neither surgical delay nor patient injuries have been stated.
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
H3, h6: the device, which was used in a procedure, was returned for evaluation.The evaluation was performed by the supplier and could confirm the customer complaint for the device has a damaged lens.A visual inspection was performed and showed the scope to have distal tip and fiber damage and a chipped compact lens.This damage is caused by contact with another source.A dhr review was performed and showed no ncmr's or deviations associated with the serial number.A review of the complaint history records for the listed part revealed no prior complaints for the listed serial number.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.No manufacturing related defects were observed.

• Brand Name: SVCE REPL ASCOPE 1.9MM X 30
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 8353983
• Report Number: 3003604053-2019-00015
• Device Sequence Number: 11162506
• Product Code: HRX
• UDI-Device Identifier: 03596010125569
• UDI-Public: 03596010125569
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K962075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/03/2020

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: 4184S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2019
• Initial Date Received by Manufacturer: 01/29/2019
• Supplement Date Received by Manufacturer: 03/19/2019; 01/02/2020
• Initial Report FDA Received Date: 02/20/2019
• Supplement Report FDA Received Date: 03/20/2019; 01/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1