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

Model Number T0449-01

Device Problem Pressure Problem (3012)

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

Event Date 04/23/2018

Event Type  malfunction  

Event Description

It was reported that the device had a fluctuating pressure during procedure causing shoulder extravasated.No patient injury was reported.

Manufacturer Narrative

H10: h3, h6: an evaluation was performed by the supplier and could not confirm the customer complaint for the device had a fluctuating pressure.A visual inspection was performed and showed no damage or misuse.Functional inspection was performed and indicated the returned device passed all criteria.This included a pressure test with a result of pass.No manufacturing related defects were observed.

• Brand Name: TUBE SET STERILE A127 PUMP
• Type of Device: INSUFFLATOR, HYSTEROSCOPIC
• 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 ; arthrocare corporation; 7000 west william cannon drive; austin, 78735 united states
• MDR Report Key: 7527662
• MDR Text Key: 108865917
• Report Number: 3003604053-2018-00073
• Device Sequence Number: 1
• Product Code: HIG
• UDI-Device Identifier: 04056702003678
• UDI-Public: (01)04056702003678(17)211130(10)4011667
• Combination Product (y/n): N
• PMA/PMN Number: K031616
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/21/2018

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 Expiration Date: 10/30/2021
• Device Model Number: T0449-01
• Device Catalogue Number: T0449-01
• Device Lot Number: 4011667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/14/2018
• Initial Date FDA Received: 05/18/2018
• Supplement Dates Manufacturer Received: 12/11/2018
• Supplement Dates FDA Received: 09/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1