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

Model Number	ST-CR
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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.
Additional Manufacturer Narrative
This supplemental report is to inform that upon further review, this is not a reportable malfunction.The initial medwatch reported that after the box was opened, it was discovered that the device was missing the stopper that keeps the handle from falling off, and was sent out of caution.Upon evaluation of the device, the washer was confirmed to be missing, which is a non-reportable malfunction.Per the legal manufacturer, this issue is not likely to cause or contribute to death or serious injury if the malfunction were to recur.

• Brand Name: STERILIZATION TRAY, SINGLE LAYER CYSTOSCOPY
• Common Device Name: 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
• Report Number: 3003790304-2023-00152
• Device Sequence Number: 17982573
• Product Code: FSM
• UDI-Device Identifier: 00821925007857
• UDI-Public: 00821925007857
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K944025
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/02/2024

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2023
• Supplement Date Received by Manufacturer: 05/04/2023; 01/29/2024
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 05/05/2023; 02/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown