MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ARTHROSCOPE,ACLV,2.7X30DEG,

Catalog Number 7205681

Device Problem Crack (1135)

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

Event Date 01/15/2018

Event Type  malfunction  

Event Description

It was reported that the device had cracked lens.There was no delay or patient injury reported.

Event Description

There was no backup device available.

Manufacturer Narrative

An evaluation was performed by the supplier and could confirm the customer complaint that the device had cracked lens.A visual inspection was performed and showed the scope to have bent outertube with distal tip and fiber damage.This is caused by contact with another source.No manufacturing related defects were observed.

• Brand Name: ARTHROSCOPE,ACLV,2.7X30DEG,
• Type of Device: 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: jim gonzales ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 7242869
• MDR Text Key: 99100076
• Report Number: 3003604053-2018-00021
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/20/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 7205681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/15/2018
• Initial Date FDA Received: 02/05/2018
• Supplement Dates Manufacturer Received: 01/15/2018; 02/15/2018
• Supplement Dates FDA Received: 02/06/2018; 02/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1