MAUDE Adverse Event Report: GYRUS ACMI, INC CYSTOURETHROSCOPE STANDARD OBTURATOR, 23FR

Model Number	E123-O
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation confirmed the reported issue as the tip was observed to be sharp, deformed and broken off.The red dot on the release button was found missing.Device history records were reviewed and showed the product met all specifications upon release.Based on device evaluation results, the reported failure was most likely due to user mishandling.As stated in instructions for use (ifu) advises "study this manual and other labeling thoroughly for safe handling and storage.Misuse of instruments can cause injury to the patient and could have an adverse effect on the procedure being performed.Do not drop instruments or allow them to be struck by other objects.Olympus will continue to monitor complaints for this device.
Event or Problem Description
It was reported that the device handle was found damaged, the tip was found broken.There were no further details provided regarding the reported event.No patient involvement reported.No user injury reported.

• Brand Name: CYSTOURETHROSCOPE STANDARD OBTURATOR, 23FR
• Common Device Name: CYSTOURETHROSCOPE STANDARD OBTURATOR, 23FR
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 11123259
• Report Number: 1519132-2021-00002
• Device Sequence Number: 689061
• Product Code: FEC
• UDI-Device Identifier: 00821925002371
• UDI-Public: 00821925002371
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: FEC
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/06/2021

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: E123-O
• Device Lot Number: CW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 01/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1