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

Model Number	7209807
Medical Device Problem Codes	Break (1069); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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.
Additional 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
• Common Device Name: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): SMITH & NEPHEW UNITED INC; 75 s. meridian ave; oklahoma city OK 73107
• MDR Report Key: 7960437
• Report Number: 1643264-2018-02066
• Device Sequence Number: 1681614
• Product Code: HIH
• UDI-Device Identifier: 10884521749900
• UDI-Public: 10884521749900
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K132015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 09/18/2018
• Supplement Date Received by Manufacturer: 11/05/2018
• Initial Report FDA Received Date: 10/12/2018
• Supplement Report FDA Received Date: 11/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1