MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HYST. FLUID MGMT SYSTEM CONTROL UNIT

Model Number 7210164

Device Problem Insufficient Information (3190)

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

Event Date 08/14/2014

Event Type  Injury  

Event Description

It was reported that during an operative hysteroscopy using a hyst.Fluid mgmt system control unit, there was a 3.0 liter fluid deficit.The procedure lasted for 90 minutes.The patient stayed in recovery for a few extra hours.There were no malfunctions of the device reported during the procedure.No other information is available at this time.

Manufacturer Narrative

(b)(4).

• Brand Name: HYST. FLUID MGMT SYSTEM CONTROL UNIT
• Type of Device: HYST. FLUID MGMT SYSTEM CONTROL UNIT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 651
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 651
• Manufacturer Contact: brenda driscoll ; 150 minuteman road; andover, MA 01810 ; 9787491462
• MDR Report Key: 4107723
• MDR Text Key: 4696455
• Report Number: 1643264-2014-00026
• Device Sequence Number: 1
• Product Code: HIG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031616
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 7210164
• Device Catalogue Number: 7210164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/25/2014
• Initial Date FDA Received: 09/22/2014
• 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
• Patient Outcome(s): Hospitalization