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

Catalog Number 7210164

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Operates Differently Than Expected (2913)

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

Event Date 12/31/2012

Event Type  malfunction  

Manufacturer Narrative

Evaluation is not possible as the unit is not being returned.Representative wanted the problem logged in the complaint system ((b)(4)).Unit has been in the field over a year now and has not been returned since original delivery.Unable to speculate the origin of the problem they experienced.(b)(4).

Event Description

It was reported that during a hysteroscopy using a fluid management system control unit, that the functional unit did not read deficit correctly after calibration.It was also reported that the surgical case proceeded and fluid calculations were performed by the staff manually.Post op the unit was rebooted and recalculated and appeared to operate correctly.No further issues were observed.(b)(4).

• 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: 5015896
• MDR Text Key: 24577646
• Report Number: 1643264-2015-00100
• 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,health
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Report Date: 12/31/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7210164
• Device Lot Number: 1109CM288
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/19/2015
• Date Device Manufactured: 02/13/2012
• 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