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

Model Number 7210164

Device Problem Insufficient Information (3190)

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Date 05/14/2015

Event Type  Death  

Event Description

During a myomectomy ¿ removal of two fibroids, it was reported that the fluid absorption was high during the procedure.At a fluid deficit of 2500cc, the doctor was asked if the case would be concluded based on the fluid deficit.The doctor elected to complete the procedure.The tissue removal procedure ran normal.Once they started pulling back the truclear tower, the staff started to surround the patient.The patient coded.The laparoscopic portion of procedure was cancelled.The patient was brought to the i.C.U.And was initially reported to have been okay.Additional information received on (b)(6) 2015 stated the patient passed away on (b)(6) 2015.Fluid management devices that could have been used in the procedure: hysteroscopic fluid monitor system ref: 7210165 sn: (b)(4), vacuum regulator model: pm3600 sn: (b)(4), truclear control unit ref: (b)(4) sn: (b)(4), footpedal ref: (b)(4) sn: (b)(4).

Manufacturer Narrative

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

Event Description

During a myomectomy ¿ removal of two fibroids, it was reported that the fluid absorption was high during the procedure.At a fluid deficit of 2500cc, the doctor was asked if the case would be concluded based on the fluid deficit.The doctor elected to complete the procedure.The tissue removal procedure ran normal.Once they started pulling back the truclear tower, the staff started to surround the patient.The patient coded.The laparoscopic portion of procedure was cancelled.The patient expired in the operating room.Fluid management devices that could have been used in the procedure: hysteroscopic fluid monitor system ref: (b)(4) sn: (b)(4).Vacuum regulator model: pm3600 sn: (b)(4).Truclear control unit ref: (b)(4), sn: (b)(4), footpedal ref: (b)(4), sn: (b)(4), truclear morcellator (complaint (b)(4)).

Manufacturer Narrative

Date of death (b)(6) 2015.Description updated with date of death.(b)(4).

Manufacturer Narrative

The principal device, a hysteroscopy fluid management system control unit, along with eleven concomitant devices reported to have been used during the event were returned for evaluation.A review of the device history records, instruction for use manuals, as well as visual and functional evaluation of the equipment reported to have been used during the case was performed and no product deficiencies were identified that could have contributed to the event.There does not appear to be any direct relationship between these devices and the reported event.The root cause of this event could not be determined with confidence as there were no deficiencies identified with the devices or labeling of the product which could have contributed to the event.

• Brand Name: HYST. FLUID MGMT SYSTEM CONTROL UNIT
• Type of Device: INSUFFLATOR, HYSTEROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer Contact: meaghan atwell ; 150 minuteman road; andover, MA 01810 ; 9787491317
• MDR Report Key: 4786774
• MDR Text Key: 5876081
• Report Number: 1643264-2015-00014
• 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: User Facility,Company Representative,company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/14/2015

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?: No
• Device Operator: Health Professional
• Device Model Number: 7210164
• Device Catalogue Number: 7210164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/14/2015
• Initial Date FDA Received: 05/21/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/12/2015; 09/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2006
• 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): Death
• Patient Age: 42 YR