MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRUCLEAR INCISOR PLUS BLADE 2.9; HYSTEROSCOPE (AND ACCESSORIES)

Catalog Number 72202536

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

Patient Problems Respiratory Distress (2045); Complaint, Ill-Defined (2331)

Event Date 10/01/2015

Event Type  Injury  

Manufacturer Narrative

The site has indicated that the devices wil not be returned for evaluation.Due to this fact we are unable to determine what may have caused the user to experience the reported incident.(b)(4).

Event Description

It was reported during a hysteroscopy, d&c, polypectomy procedure that post-procedure the patient crashed.Nothing happened to the patient after that.Additional information indicated that the patient coded while she was in the operating room.The specifics regarding medical intervention were not available, although there was talk of compressions being given to the patient (not confirmed).During the surgery, the patient was initially under local anesthesia and was coughing and having other issues with respiration, which required the anesthesia team to put her to sleep.The patient was brought to recovery; the patient is healthy.A hysteroscope for diagnostic hysteroscopy was also used in the procedure.

• Brand Name: TRUCLEAR INCISOR PLUS BLADE 2.9
• 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 ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 5181771
• MDR Text Key: 29412090
• Report Number: 3003604053-2015-00103
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103389
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/01/2015

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: 72202536
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/01/2015
• Initial Date FDA Received: 10/27/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other