MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VIDEOARTHROSCOPE HD 4MM X 30 DEG

Catalog Number	72202961S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/22/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a knee surgery there was a scratch on the distal tip of the scope.A backup device was used to complete the surgery.There was a surgical delay greater than 30 minutes.
Additional Manufacturer Narrative
The device, which was used in a procedure, was returned for evaluation.The evaluation was performed by the supplier and could not confirm the customer complaint for there was a scratch on the distal tip of the scope.A visual inspection was performed and showed no damage to the scope.Functional inspection was performed and showed when the scope was attached to the camera system it provided a clear sharp image.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.
Additional Manufacturer Narrative
The device, was used in a case, 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 serial number provided.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: VIDEOARTHROSCOPE HD 4MM X 30 DEG
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 9088375
• Report Number: 3003604053-2019-00123
• Device Sequence Number: 2158169
• Product Code: HRX
• UDI-Device Identifier: 00885554024203
• UDI-Public: 00885554024203
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/26/2019

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: 72202961S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2019
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/29/2019
• Supplement Date Received by Manufacturer: 10/15/2019; 11/25/2019
• Initial Report FDA Received Date: 09/19/2019
• Supplement Report FDA Received Date: 10/19/2019; 11/26/2019
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown