MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VAS, HD, AC, 4MM X 30 DEG; ARTHROSCOPE

Catalog Number	72202959
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/13/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery when the doctor went to look in it, there was a cracked.No delay and a back up was available to complete the procedure.The display was completely lost while inside the patient, however, there were no other tools inside the patient when it happened.No patient injury was reported.
Additional Manufacturer Narrative
An evaluation was performed by the supplier and could confirm the customer complaint for the scope was cracked.A visual inspection was performed and showed the scope to have distal tip damage and a particulate under the negative lens.This damage is caused by contact with another source.No manufacturing related defects were observed.

• Brand Name: VAS, HD, AC, 4MM X 30 DEG
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 8957789
• Report Number: 3003604053-2019-00113
• Device Sequence Number: 16666123
• Product Code: HRX
• UDI-Device Identifier: 00885554018783
• UDI-Public: 00885554018783
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K043395
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2019

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: 72202959
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Initial Date Received by Manufacturer: 08/16/2019
• Supplement Date Received by Manufacturer: 09/18/2019
• Initial Report FDA Received Date: 09/03/2019
• Supplement Report FDA Received Date: 09/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1