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

Model Number	ST-CR
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Company representative reported with an issue of sterilization tray have cracked.Per the report, two trays have cracked in which the customer only bought these trays back in september.The issue was found during reprocessing.There was no patient involvement on this reported event.No user injury was reported.This event includes two reports : report with patient identifier (b)(6) model st-cr, sn (b)(6) (tray 1 of 2).Report with patient identifier (b)(6) model st-cr, sn (b)(6) (tray 2 of 2).This report being submitted is for report with patient identifier (b)(6) model st-cr, sn (b)(6) (tray 2 of 2).
Additional Manufacturer Narrative
Is only a 90 day warranty for this item.Bb/ 417868 (b)(6) 2023 the subject device was not returned for evaluation.Per the follow up communication with the customer, it was conveyed the device will not be returned as warranty was not granted as the warranty date for return had passed and therefore customer will not be returning the device.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.
Additional Manufacturer Narrative
This supplemental report is to provide a correction to the initial medwatch report (mdr).The initial mdr was inadvertently submitted as a reportable malfunction as there was no reportable malfunction related to the subject device captured in this complaint.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: TRAY, SURGICAL, INSTRUMENT
• 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: 17214196
• Report Number: 3003790304-2023-00250
• Device Sequence Number: 14199374
• Product Code: FSM
• UDI-Device Identifier: 00821925007857
• UDI-Public: 00821925007857
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2023
• Supplement Date Received by Manufacturer: 02/02/2024
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 02/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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