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

Catalog Number 7210164

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 02/03/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the fluid management system control unit showed a deficit higher than what was manually counted.Allegedly, the readout showed a deficit of 1900 and the actual manually counted deficit was 900.Due to the high deficit, the surgeon decided to abort the procedure.It is noted that the patient's uterus might have been perforated (pending confirmation).

Manufacturer Narrative

Device investigation narrative - an evaluation was performed by the supplier and could not confirm the customer complaint for the fluid management system control unit showed a deficit higher than what was manually counted.A visual inspection was performed and showed the device has been used in the field.One of the screws from the bottom panel was missing.Functional inspection indicated the returned device passed all criteria.Deficit testing could not be performed due to the fluid management system stand not being returned.No manufacturing related defects were observed with the control unit.Smith & nephew will continue to monitor.No further investigation is required.(b)(4).

• Brand Name: S+N HYSTEROSCOPIC FMS 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 james gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 5444614
• MDR Text Key: 39014184
• Report Number: 1643264-2016-00025
• 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
• Reporter Occupation: Nurse
• 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: 02/18/2016
• Is this an Adverse Event Report?: No
• 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: 02/11/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2015
• 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