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

Catalog Number 7210164

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Perforation (2001)

Event Date 01/15/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during a hysteroscopic myomectomy procedure that surgeon lost distension while using the fluid management system.It was stated that the surgeon made a false perforation while dilating and believed the fluid management system was at fault when distention was lost.The procedure was cancelled and rescheduled.A backup was not available.

Manufacturer Narrative

A visual inspection was performed and showed the device has been used in the field.Functional inspection indicated the returned device passed all criteria; this included the sensor test with a result of pass.Rpm on the motor were tested and were found to be well within the tolerance permitted.No manufacturing related defects were observed.After the evaluation the root cause for the reported issue could not be determined.

• 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 ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 5439736
• MDR Text Key: 38286932
• Report Number: 1643264-2016-00024
• 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,consum
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 02/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7210164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2014
• 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): Required Intervention