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

Model Number 7210164

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 01/09/2015

Event Type  Injury  

Event Description

During a hysteroscopic myomectomy using a hysteroscopic fluid management system control unit, it was reported that the deficit was at 600 ml.The surgeon continued to work for approximately fifteen minutes as the deficit surpassed the recommended parameters and went to 6000 ml.The patient turned blue and her chest became rigid.The patient was admitted to the icu and stayed for several days.No other information is available at this time.

Manufacturer Narrative

The device was marked as available for evaluation; although anticipated, the device has not yet been received.(b)(4).

• Brand Name: HYSTEROSCOPIC FLUID MANAGEMENT SYSTEM
• 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: 4513095
• MDR Text Key: 5488649
• Report Number: 1643264-2015-00005
• 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: Nurse
• Type of Report: Initial
• Report Date: 01/15/2015

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 7210164
• Device Catalogue Number: 7210164
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2015
• Initial Date FDA Received: 02/12/2015
• Date Device Manufactured: 05/15/2012
• 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; Life Threatening; Required Intervention