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

Catalog Number 72202087F

Device Problems Crack (1135); Unexpected Shutdown (4019)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/22/2019

Event Type  malfunction  

Event 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.

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.

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
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 8680720
• MDR Text Key: 147456079
• Report Number: 3003604053-2019-00066
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00885556572870
• UDI-Public: 00885556572870
• Combination Product (y/n): N
• PMA/PMN Number: K962075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72202087F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Date Manufacturer Received: 08/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 77