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

Model Number	E123-O
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device has not yet been received for evaluation.The cause of the issue is unknown at this time.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Event or Problem Description
Customer reported with an issue of " the tip is broken off".The issue occurred during reprocessing.There was no patient harm , no user injury reported due to the event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The initial reporters occupation was inadvertently entered into the initial medwatch report incorrectly.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Upon completion of the evaluation, there were no problems found with the distal tip.However, the obturator knob at the proximal end was found damaged, and the red dot on the release button was missing.It¿s likely the damaged knob was due to improper handling during device reprocessing.The root cause of the damaged knob was unable to be identified.The device was manufactured in june 2016.However, the specific date is unknown.Olympus will continue to monitor field performance for this device.

• Brand Name: CYSTOURETHROSCOPE STANDARD OBTURATOR, 23FR
• Common Device Name: RIGID CYSTOURETHROSCOPE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14519880
• Report Number: 8010047-2022-09004
• Device Sequence Number: 4793728
• Product Code: FEC
• UDI-Device Identifier: 00821925002371
• UDI-Public: 00821925002371
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2022

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: FW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2022
• Supplement Date Received by Manufacturer: 06/16/2022
• Initial Report FDA Received Date: 05/26/2022
• Supplement Report FDA Received Date: 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown