MAUDE Adverse Event Report: COVIDIEN MANSFIELD TRUCLEAR; HYSTEROSCOPE (AND ACCESSORIES)

Model Number	7209807
Medical Device Problem Codes	Contamination (1120); Material Fragmentation (1261)
Health Effect - Clinical Code	No Patient Involvement (2645)
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, prior to use, the device had shaved on inside and rusty as seen with boroscope.There was no patient involvement.

• Brand Name: TRUCLEAR
• Common Device Name: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN MANSFIELD; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 9927137
• Report Number: 1282497-2020-00012
• Device Sequence Number: 654664
• Product Code: HIH
• UDI-Device Identifier: 10884521749924
• UDI-Public: 10884521749924
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/05/2020

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 04/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1