MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRUCLEAR ULTRA PLUS DEVICE; HYSTEROSCOPE (AND ACCESSORIES)

Catalog Number 72203012

Device Problems Bent (1059); Break (1069); Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/18/2015

Event Type  malfunction  

Manufacturer Narrative

Visual inspection and functional testing could not be performed because the device in question was not returned for evaluation.Thus, the complaint could not be verified, nor could a root cause be determined with confidence.A review of the device history records and complaint files confirmed that no additional complaints have been reported and no abnormalities were noted during the manufacturing process for this lot.There are no indications that would suggest that the device did not meet product specifications upon release into distribution.

Event Description

It was reported that during a hysteroscopy with fibroid removal the device broke in the patient.A tissue removal device was used to remove scope, and then removed the blade from the scope.Healthcare professional noticed it fell in right away and acted immediately.The blade broke inside the patient but did not fall into the patient or off the device.The blade cracked and bent outward.A backup device was available to complete.There was no reported patient injury.No other complications were noted.

• Brand Name: TRUCLEAR ULTRA PLUS DEVICE
• 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: 5966753
• MDR Text Key: 55614301
• Report Number: 3003604053-2016-00069
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Catalogue Number: 72203012
• Device Lot Number: C06961
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2015
• Initial Date FDA Received: 09/21/2016
• Date Device Manufactured: 01/01/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1