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

Model Number 72202976

Device Problem Insufficient Information (3190)

Patient Problems Perforation (2001); Complaint, Ill-Defined (2331)

Event Date 09/02/2014

Event Type  Injury  

Event Description

Doctor was performing a hysteroscopy and after dilation which was reported to be difficult because the cervix was stenotic, the doctor proceeded to insert the scope with inflow on.As he entered the cavity the wheel was spinning during distention and still remained spinning after the cavity was distended at 400 ml.It was reported that fluid was being lost, the floor and butt drape were found to be clear.Deficit climbed to 1000 ml and the doctor noticed a perforation in the uterus.The surgeon then turned off inflow and removed the scope.The doctor could not determine if the perforation was done during dilation or when scope was put in.When the doctor first entered, he noted that he was in a false passage.After removal of the scope, the input was 1,360 ml and the deficit was 1,220 ml which left 140 ml output.The doctor said that the wall of the uterus prior to dilation was very thin and perforation could have already been there but did not show until after dilation.Patient had no adverse reactions.The scope used was a 5.0 p/n 72202976 and the sheath p/n 72202977.There was no further injury to the patient after the perforation.The doctor was unsure whether he perforated while dilating, or if he perforated with the scope.The patient went to recovery after the procedure.No blade was used during the procedure.

Manufacturer Narrative

(b)(4).

• Brand Name: TRUCLEAR OPERATIVE HYSTEROSCOPE 5.0
• Type of Device: HYSTEROSCOPE & 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: meaghan atwell ; 150 minuteman road; andover, MA 01810 ; 9787491317
• MDR Report Key: 4121983
• MDR Text Key: 4918664
• Report Number: 3003604053-2014-00012
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 09/02/2014

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 Model Number: 72202976
• Device Catalogue Number: 72202976
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/02/2014
• Initial Date FDA Received: 09/26/2014
• 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): Other
• Patient Age: 70 YR