MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRUCLEAR FOOTSWITCH; HYSTEROSCOPE (AND ACCESSORIES)

Catalog Number 7209820

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 04/24/2015

Event Type  malfunction  

Manufacturer Narrative

Evaluation was not possible, as the device has not been returned.A complaint history review has not identified additional complaints for this serial number on file.Unit shipped new to customer on (b)(6) 2015.Due to this fact we are unable to determine what may have caused the user to experience the reported incident.No further investigation is warranted at this time.(b)(4).

Event Description

During a hysteroscopy procedure, the window lock was not working and the footswitch would not activate the blade.There were no patient injuries or complications.There was no back up device available.There was a ten minute delay in the procedure.

• Brand Name: TRUCLEAR FOOTSWITCH
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• 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: 5176688
• MDR Text Key: 29853488
• Report Number: 1643264-2015-00167
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031787
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/24/2015

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: 7209820
• Device Lot Number: YG2597
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/27/2015
• Initial Date FDA Received: 10/26/2015
• Date Device Manufactured: 03/02/2015
• 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