MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. AMSCO; STEAM STERILIZER

Model Number	AMSCO 600 STEAM STERILIZER
Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that their amsco 600 sterilizer was "alarming" and emitting a burning smell.No report of injury.
Additional Manufacturer Narrative
The investigation into the reported event is in process; a follow-up report will be submitted when additional information becomes available.
Additional Manufacturer Narrative
The fda premarket submission number listed in our initial mdr # 3005899764-2024-00038 was for the v-pro max sterilizer.Our follow-up investigation determined that the reported event occurred with a v-pro max 2 sterilizer, therefore, the fda premarket submission number does not apply to this device.
Additional Manufacturer Narrative
A steris service technician arrived on-site to inspect the amsco 600 sterilizer and found that the unit's cable assembly was burned, and the proximity sensor was damaged.The device history record was reviewed and confirmed the unit was manufactured according to specifications; no abnormalities were noted.The technician replaced the cable assembly and proximity sensor, tested the unit, confirmed it to be operational, and returned it to service.The damaged cable assembly and proximity sensor were returned for further evaluation.Although inconclusive, the evaluation results determined the possibility of both the connector and sensor being damaged prior to the event.This may have caused the unit to short circuit.It is unknown how or when the damage occurred to the cable assembly and proximity sensor.A 2-year complaint review determined this to be an isolated event.No additional issues have been reported.
Additional Manufacturer Narrative
The information submitted under mdr # 3005899764-2024-00038-02 was inadvertently filed and should have been submitted under 3005899764-2024-00046-02.

• Brand Name: AMSCO
• Common Device Name: STEAM STERILIZER
• Manufacturer (Section D): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, 67190 ; MX 67190
• Manufacturer (Section G): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, 67190 ; MX 67190
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 19983613
• Report Number: 3005899764-2024-00038
• Device Sequence Number: 16825620
• Product Code: FLE
• UDI-Device Identifier: 00724995179229
• UDI-Public: (01)00724995179229(11)210716
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K232485
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/14/2024

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: AMSCO 600 STEAM STERILIZER
• Device Catalogue Number: EF1101242
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 11/19/2024; 11/20/2024; 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2021
• 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