MAUDE Adverse Event Report: GYRUS ACMI, INC. STERILIZATION TRAY, SINGLE LAYER CYSTOSCOPY

Model Number ST-CR

Device Problem Component Missing (2306)

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

Event Date 03/15/2023

Event Type  malfunction  

Manufacturer Narrative

The subject device has not yet returned for evaluation.Follow up is in progress.Supplemental report(s) will be submitted should any relevant new information is available and or received.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

Company representative in behalf of the customer reported an out of box failure.It was reported device was missing the stopper that keeps the handle from falling off".According to the report, the customer stated "the box arrived and there was no sign of damage; however, it was definitely damaged out of the box, customer per the report stated the stopper was not there to start with per the observation".The issue found at installation.There was no patient involvement on this reported event.No harm was reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on device return evaluation.The subject device was received and evaluated.The reported issue was confirmed.The device was returned in its original box which has a minor dent on the bottom corner, however, no heavy impact.Observed that no bubble wrap or foam placed inside the box to protect the tray.Visual inspection of the tray as received condition confirmed the reported complaint of missing stopper on one of the handles.The stopper (internal tooth lock washer) that holds one side of the handle rod was missing and not found inside the packaging or tray.The rod is straight and has no physical damage.However, the other handle is in good condition, and both latches could be snapped on to lock in place.The tray appears to be in new condition with the ifu manual taped on the bottom of tray.The molded basin is also intact.Investigation is ongoing.This report will be supplemented accordingly following investigation.

• Brand Name: STERILIZATION TRAY, SINGLE LAYER CYSTOSCOPY
• Type of Device: STERILIZATION TRAY
• Manufacturer (Section D): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer (Section G): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16721381
• MDR Text Key: 313120738
• Report Number: 3003790304-2023-00152
• Device Sequence Number: 1
• Product Code: FSM
• UDI-Device Identifier: 00821925007857
• UDI-Public: 00821925007857
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ST-CR
• Device Lot Number: 000252144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1