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

Model Number	T0449-01
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/23/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device had a fluctuating pressure during procedure causing shoulder extravasated.No patient injury was reported.
Additional 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
• Common Device Name: 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
• Report Number: 3003604053-2018-00073
• Device Sequence Number: 176095
• Product Code: HIG
• UDI-Device Identifier: 04056702003678
• UDI-Public: (01)04056702003678(17)211130(10)4011667
• Combination Product (Y/N): N
• PMA/510(K) Number: K031616
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2018
• Supplement Date Received by Manufacturer: 12/11/2018; Not provided
• Initial Report FDA Received Date: 05/18/2018
• Supplement Report FDA Received Date: 09/04/2023; 12/21/2018
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown