MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRUCLEAR OPERATIVE HYSTEROSCOPE 8.0; HYSTEROSCOPE AND ACCESSORIES

Catalog Number 7209208

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 04/24/2013

Event Type  Injury  

Event Description

During a literature review the following information was presented: during a hysteroscopic procedure using a truclear operative hysteroscope 8.0 to remove placental remnants, a fluid deficit occurred.The patient experienced fluid deficit >2500ml resulting in incomplete placental remnants.A revision surgery was performed to complete remnant removal.

Manufacturer Narrative

Additional information: literature citation: blikkendall, mathijs d., tjalina w.O.Hamerlynck, miriam m.F.Hanstede, frank wilem jansen, benedictus c.Schoot (2013).An alternative approach for removal of placental remnants: hysteroscopic morcellation.The journal of minimally invasive gynecology (2013) 20, 796-802.(b)(4).

• Brand Name: TRUCLEAR OPERATIVE HYSTEROSCOPE 8.0
• 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: jim gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 4890121
• MDR Text Key: 6068933
• Report Number: 3003604053-2015-00053
• 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: Other,Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/03/2015

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: 7209208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/03/2015
• Initial Date FDA Received: 07/04/2015
• 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): Other