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

Catalog Number 72202961S

Device Problem Connection Problem (2900)

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

Event Date 10/30/2019

Event Type  malfunction  

Event Description

It was reported that during a shoulder arthroscopy the scope lens did not attach properly.The procedure was completed with a back up device with a delay greater than 30 minutes.No patient injuries were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

Additional narrative.The device, which was used in a procedure, was returned for evaluation.The evaluation was performed by the supplier and could confirm the customer complaint for the lens did not attach properly.A visual inspection was performed and showed the scope to have distal tip damage, a dented outertube and broken lenses.This damage is caused by contact with another source.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.No manufacturing related defects were observed.Correction in report source: foreign should be marked.Other specify: costa rica.

• Brand Name: VIDEOARTHROSCOPE HD 4MM X 30 DEG
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 9376041
• MDR Text Key: 183482671
• Report Number: 3003604053-2019-00137
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00885554024203
• UDI-Public: 00885554024203
• Combination Product (y/n): N
• PMA/PMN Number: K043395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72202961S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2019
• Date Manufacturer Received: 12/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1