MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVCE REP HANDPIECE HYSTER MORCELLATOR; HYSTEROSCOPE (AND ACCESSORIES)

Catalog Number 7209807S

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

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

Event Date 01/06/2014

Event Type  malfunction  

Manufacturer Narrative

Complaint of functional failure could not be reproduced.Product passed functional testing in forward, reverse, and oscillate with blade installed.All functions perform as expected.No problem found.(b)(4).

Event Description

It was reported that during an operative hysteroscopy procedure, the functional inserted blade, had her tap foot pedal to get tissue stuck to tip of blade thru blade it was reported that when she tapped the foot pedal, the blade did nothing.She tried to reset everything and tried again and it just continued to do nothing.The facility was instructed how to check error code which was e6 on control unit and the hand piece motor failed.There was no back up device available.The procedure delay was 20 minutes.

• Brand Name: SVCE REP HANDPIECE HYSTER MORCELLATOR
• 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: 5038657
• MDR Text Key: 25152010
• Report Number: 1643264-2015-00147
• 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
• Report Date: 01/07/2014

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: 7209807S
• Device Lot Number: YE00101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2005
• 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