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

Model Number E123-O

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/02/2022

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 300579786
• Report Number: 8010047-2022-09004
• Device Sequence Number: 1
• Product Code: FEC
• UDI-Device Identifier: 00821925002371
• UDI-Public: 00821925002371
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 06/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1