MAUDE Adverse Event Report: MITG-OKLAHOMA CITY TRUCLEAR SHEATH; HYSTEROSCOPE (AND ACCESSORIES)

Model Number	72204753
Medical Device Problem Codes	Bent (1059); Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/02/2017
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 the cleaning process, two same devices were damaged.The sheaths were both bent and one was broken in half when someone tried to straighten it.There was no patient involvement.

• Brand Name: TRUCLEAR SHEATH
• Common Device Name: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): MITG-OKLAHOMA CITY; 75 s. meridian ave; oklahoma OK 73107
• MDR Report Key: 6984565
• Report Number: 1643264-2017-21124
• Device Sequence Number: 11042193
• Product Code: HIH
• UDI-Device Identifier: 00885556583685
• UDI-Public: 00885556583685
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K152143
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/27/2017

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: 72204753
• Device Catalogue Number: 72204753
• Device Lot Number: 1444615
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2017
• Initial Report FDA Received Date: 10/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1