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

Catalog Number 7210164

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pulmonary Edema (2020)

Event Date 05/03/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the hysteroscopic fluid management system control unit was used in a procedure in which the patient developed pulmonary edema.It was reported that the fluid deficit was "getting too high" and following the procedure the patient was reported to have developed pulmonary edema.Patient update reports that the patient is doing ok.There is no report of a device malfunction or procedure delay associated with this event.

Manufacturer Narrative

A review of the device history record was performed which confirmed no inconsistencies.

• 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: james gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 5643807
• MDR Text Key: 44837176
• Report Number: 1643264-2016-00065
• 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,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7210164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/03/2016
• Initial Date FDA Received: 05/10/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Life Threatening