MAUDE Adverse Event Report: SMITH & NEPHEW UNITED INC TRUCLEAR; HYSTEROSCOPE (AND ACCESSORIES)

Model Number 7209807

Device Problems Break (1069); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 09/17/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during testing, the metal piece snapped out on the shaft of the hand piece.There was no patient involvement.No further information available.

Manufacturer Narrative

Investigation summary: one device was received for evaluation.The returned sample did not meet specification as received.The visual inspection found that the nipple to attach suction had broken.The customer reported that during testing, the metal piece snapped out of the hand piece.Verified customer complaint that the metal piece snapped out of the hand piece.The investigation found the most probable cause of the reported event to be the snapped metal piece.Hand piece was scrapped.If information is provided in the future, a supplemental report will be issued.

• Brand Name: TRUCLEAR
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): SMITH & NEPHEW UNITED INC; 75 s. meridian ave; oklahoma city OK 73107
• Manufacturer (Section G): SMITH & NEPHEW UNITED INC; 75 s. meridian ave; oklahoma city OK 73107
• Manufacturer Contact: lisa hernandez ; 5920 longbow drive; boulder, CO 80301 ; 2034925563
• MDR Report Key: 7960437
• MDR Text Key: 123524503
• Report Number: 1643264-2018-02066
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 10884521749900
• UDI-Public: 10884521749900
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/28/2018

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 Model Number: 7209807
• Device Catalogue Number: 7209807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2018
• Initial Date Manufacturer Received: 09/18/2018
• Initial Date FDA Received: 10/12/2018
• Supplement Dates Manufacturer Received: 11/05/2018
• Supplement Dates FDA Received: 11/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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