MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VIDEOARTHORSCOPE HD 4MM X 70 DEG; ARTHROSCOPE

Catalog Number	72202962S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/12/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgery the can't see through the scope.A backup device was used to complete the surgery.No significant delay or patient injury reported.
Event or Problem Description
It was reported that during a right hip scope surgery, labral repair they can't see through the scope.A backup device was used to complete the surgery.No significant delay or patient injury reported.
Additional Manufacturer Narrative
An evaluation was performed by the supplier and could confirm the customer complaint for the scope had no image.A visual inspection was performed and showed the scope to have distal tip and fiber damage.This damage is caused by contact with another source.No manufacturing related defects were observed.

• Brand Name: VIDEOARTHORSCOPE HD 4MM X 70 DEG
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 8396548
• Report Number: 3003604053-2019-00027
• Device Sequence Number: 2029949
• Product Code: HRX
• UDI-Device Identifier: 00885554024210
• UDI-Public: 00885554024210
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K043395
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/29/2019

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: 72202962S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2019
• Initial Date Received by Manufacturer: 02/14/2019
• Supplement Date Received by Manufacturer: 03/07/2019; 03/28/2019
• Initial Report FDA Received Date: 03/06/2019
• Supplement Report FDA Received Date: 03/07/2019; 03/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 61