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

Catalog Number 7209807F

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 05/16/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the truclear hysteroscopic morcellator handpiece blade came out of the window lock and turned out 90 degrees.The blade was relocked in the cavity with a 1 minute delay reported.There was no report of patient injury.

Manufacturer Narrative

Device investigation narrative - one refurbished truclear mdu, part number 7209807f was received on june 03, 2016 and confirmed to be serial number (b)(4).A visual inspection was performed on the product and no damage was observed.Complaint of window lock malfunction could not be confirmed.Product passed functional testing including high speed testing (100-2500 rpms) with blade installed.Unit passed functional tests on a known good control unit with footswitch.Window lock function performed as expected with no trouble and blade returned to the set position every time.No problem found.(b)(4).

• Brand Name: RFB 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 5703212
• MDR Text Key: 48009639
• Report Number: 1643264-2016-00087
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7209807F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2012
• 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