MAUDE Adverse Event Report: MITG-OKLAHOMA CITY TRUCLEAR OPERATIVE HYSTEROSCOPE 8.0; HYSTEROSCOPE (AND ACCESSORIES)

Model Number	7209208
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/30/2018
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 use, the device's lens was broken.There was no patient involvement.
Additional Manufacturer Narrative
Evaluation summary: one device was received for evaluation.The returned sample did not meet specification.The reported condition was confirmed.A visual inspection was performed and showed sever residue build up on the negative lens and cracked internal lenses.This damage is caused by contact with another source and improper cleaning.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.If information is provided in the future, a supplemental report will be issued.

• Brand Name: TRUCLEAR OPERATIVE HYSTEROSCOPE 8.0
• Common Device Name: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): MITG-OKLAHOMA CITY; 150 minuteman rd.; andover MA 01810
• MDR Report Key: 7448171
• Report Number: 1643264-2018-02041
• Device Sequence Number: 1976805
• Product Code: HIH
• UDI-Device Identifier: 10884521746664
• UDI-Public: 10884521746664
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K013870
• 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,Followup
• Report Date (Section B): 08/13/2018

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: 7209208
• Device Catalogue Number: 7209208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2018
• Initial Date Received by Manufacturer: 04/09/2018
• Supplement Date Received by Manufacturer: 07/27/2018
• Initial Report FDA Received Date: 04/20/2018
• Supplement Report FDA Received Date: 08/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1