MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REFURB ASCOPE ACLV HD 30 DEG 4MM; ARTHROSCOPE

Catalog Number	72202087F
Medical Device Problem Codes	Crack (1135); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/22/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the scope lens was cracked during a shoulder arthroscopy causing a completely loss of image.A backup device was available to complete the procedure with no delay or patient injuries.
Additional Manufacturer Narrative
An evaluation was performed by the supplier and could confirm the customer complaint for the lens was cracked.A visual inspection was performed and showed the scope to have distal tip and fiber damage, a bent outertube and a broken lens.This damage is caused by contact with another source.No manufacturing related defects were observed.
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.No further investigation is required.

• Brand Name: REFURB ASCOPE ACLV HD 30 DEG 4MM
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 8680720
• Report Number: 3003604053-2019-00066
• Device Sequence Number: 16625532
• Product Code: HRX
• UDI-Device Identifier: 00885556572870
• UDI-Public: 00885556572870
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K962075
• 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,Followup
• Report Date (Section B): 08/21/2019

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: 72202087F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Initial Date Received by Manufacturer: 05/22/2019
• Supplement Date Received by Manufacturer: 07/09/2019; 08/20/2019
• Initial Report FDA Received Date: 06/07/2019
• Supplement Report FDA Received Date: 07/10/2019; 08/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 77