MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TUBE SET STERILE A127 PUMP; INSUFFLATOR, HYSTEROSCOPIC

Catalog Number T0449-01

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 04/23/2018

Event Type  malfunction  

Event Description

It was reported that at the start of a standard knee arthroscopy case the goflow tubing was inserted into the goflow fms and immediately gave an error indicating there was a fault with the new tubing.No back-up device was available.No patient injury reported.

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.

Manufacturer Narrative

An evaluation was performed by the supplier and could confirm the customer complaint for the pump immediately gave an error indicating there was a fault with the new tubing.A visual inspection was performed and showed no indications of transport damage or misuse.Functional inspection was performed and showed the transporter data had not been written onto the transporter label during assembly.The related manufacturing personnel have been notified of this issue.This is the first complaint for this failure.

• Brand Name: TUBE SET STERILE A127 PUMP
• Type of Device: INSUFFLATOR, HYSTEROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 7509731
• MDR Text Key: 108239899
• Report Number: 3003604053-2018-00068
• Device Sequence Number: 1
• Product Code: HIG
• Combination Product (y/n): N
• PMA/PMN Number: K031616
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/21/2018

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: T0449-01
• Device Lot Number: 4011234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2018
• Initial Date Manufacturer Received: 04/23/2018
• Initial Date FDA Received: 05/13/2018
• Supplement Dates Manufacturer Received: 06/13/2018; 09/20/2018
• Supplement Dates FDA Received: 06/14/2018; 09/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1