MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRUCLEAR OPERATIVE HYSTEROSCOPE 5.0; HYSTEROSCOPE (AND ACCESSORIES)

Catalog Number 72202976

Device Problems Inadequacy of Device Shape and/or Size (1583); Improper or Incorrect Procedure or Method (2017)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/01/2015

Event Type  Injury  

Manufacturer Narrative

The device has not been returned.Due to the device not being returned, we are unable to determine what may have caused the user to experience the reported incident.No further investigation is necessary at this time.In the event the sample is returned for evaluation the complaint will be reopened for additional investigation.(b)(4).

Event Description

It is reported that there was a five to ten minute delay in the case as there was an inability to dilate the cervix during a hysteroscopy/myomectomy/hta ablation.Reportedly, a small truclear scope was used then a larger one with no improvement; then went back to smaller scope.Originally the smith and nephew 5.0 scope was used, then the smith and nephew 8.0 scope was attempted but found to be too large.Finally, the surgeon returned to the smith and nephew 5.0 scope to resect tissue.It is reported that the two scopes and the hp have all been used successfully since this incident.It is alleged that the physician tried to dilate by use of a larger hospital owned scope for the hta ablation portion of the case and bent the hospital owned scope.It is reported that, days after the procedure (unsure how many days), the patient was referred to another physician for an emergency hysteroscopy.It is further reported that the patient had an emergency hysterectomy due to endometrial hemorrhage.At last report there is no information available on the patient's current condition.No device will be returned for analysis as the two scopes and the hp have all been used successfully since this incident.

• Brand Name: TRUCLEAR OPERATIVE HYSTEROSCOPE 5.0
• 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: james gonzales ; 130 forbes boulevard; mansfield, MA 02048 ; 5123585706
• MDR Report Key: 5292417
• MDR Text Key: 33348697
• Report Number: 3003604053-2015-00118
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013870
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 72202976
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/03/2015
• Initial Date FDA Received: 12/12/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/14/2015
• 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
• Patient Outcome(s): Required Intervention