MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HYSTEROSCOPIC FMS CONTROL UNIT; INSUFFLATOR, HYSTEROSCOPIC

Model Number 7210164

Device Problem Volume Accuracy Problem (1675)

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

Event Date 12/04/2014

Event Type  Injury  

Event Description

During a hysteroscopic myomectomy resection, it was reported that an excessive fluid deficit occurred.The final deficit was reported to be 3000 ml normal saline.No injury was reported to the patient.Deficit rose very quickly before the physician recognized a higher deficit than recommended.Physician abandoned case immediately after recognizing excessive deficit.Case was not completed and physician will follow up with patient to determine outcomes and course of action.Patient recovered with no incident and was sent home same day as procedure.Subsequent procedures have been performed with the fluid management system without incident.

Manufacturer Narrative

(b)(4).

• Brand Name: HYSTEROSCOPIC FMS CONTROL UNIT
• Type of Device: INSUFFLATOR, HYSTEROSCOPIC
• 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: meaghan atwell ; 150 minuteman road; andover, MA 01810 ; 9787491317
• MDR Report Key: 4377646
• MDR Text Key: 20756601
• Report Number: 1643264-2015-00001
• 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: Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 12/05/2014

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: 12/05/2014
• Initial Date FDA Received: 01/02/2015
• Date Device Manufactured: 08/08/2013
• 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): Required Intervention