MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HYSTEROSCOPIC ROTARY MORCELLATOR; HYSTEROSCOPE (AND ACCESSORIES)

Catalog Number 7209509

Device Problem Improper Flow or Infusion (2954)

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

Event Date 09/25/2014

Event Type  malfunction  

Manufacturer Narrative

Subject device was returned not returned for evaluation.A review of the device history record of this device from the supplier indicated that there were no outstanding issues related to this device during manufacturing.Per results of the investigation, there is insufficient information to determine root cause.At this time, no further investigation will be implemented.(b)(4).

Event Description

During a hysteroscopic polypectomy procedure utilizing the hysteroscopic rotary morcellator, it was reported that the surgeon locked the window of the subject device and began procedure.A loss of distention was noticed and the blade was removed.It was reported that the surgeon locked the window of the blade for a second time and loss of distention was noticed.It was reported that no back up device was available.Surgery was completed with the complained device by manually operating the suction.(b)(4).

• Brand Name: HYSTEROSCOPIC ROTARY MORCELLATOR
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer Contact: jim gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 5085731
• MDR Text Key: 26393820
• Report Number: 3003604053-2015-00093
• 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: health professional
• Reporter Occupation: Health Professional
• Report Date: 09/25/2014

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 Expiration Date: 10/31/2016
• Device Catalogue Number: 7209509
• Device Lot Number: B77377
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1