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

Model Number ST-CR

Device Problem Crack (1135)

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

Event Type  malfunction  

Event 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 1 of 2).

Manufacturer Narrative

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.

• Brand Name: STERILIZATION TRAY, SINGLE LAYER CYSTOSCOPY
• Type of Device: 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: 17214195
• MDR Text Key: 317988306
• Report Number: 3003790304-2023-00249
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2023
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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