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

Catalog Number 72202536

Device Problem Fluid/Blood Leak (1250)

Patient Problem Bowel Perforation (2668)

Event Date 10/19/2015

Event Type  Injury  

Manufacturer Narrative

Evaluation was not possible, as the device was not returned.Review of the device history records was not able to be performed as the lot number(s) were not available.Due to the device not being returned a root cause could not be determined.No further investigation is necessary at this time.

Event Description

Anatomical perforation the patient sustained a perforated bowel.The fluid deficit in this case was 600ml normal saline.The patient had surgery the following day to repair the bowel perforation.The perforation was not observed during the hysteroscopy on the monday incident date however it was reported that the case was aborted.Nothing will be returned for analysis as it was disposed of.The lot number is not available.

• 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: 5239735
• MDR Text Key: 31732452
• Report Number: 3003604053-2015-00106
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/22/2015

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/22/2015
• Initial Date FDA Received: 11/20/2015
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention