MAUDE Adverse Event Report: TERRAGENE S.A STRYKER; AUTO-READER INCUBATOR

Model Number STRYKER SLCD12

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 02/27/2023

Event Type  malfunction  

Manufacturer Narrative

There were no reported medical interventions, surgical delays, or any adverse consequences for patient and/or user with this event.Device malfunction cause the device to fail to perform its essential function and compromise the device's monitoring effectiveness, since it would not be able to process biological indicators.If this were to recur, the lack of biological indicators processing could affect the load release, which could contribute to a serious injury if it were to recur due to lack of sterile material.

Event Description

According to the user, the autoreader incubator was not working during testing.Product was scrapped by customer.

• Brand Name: STRYKER
• Type of Device: AUTO-READER INCUBATOR
• Manufacturer (Section D): TERRAGENE S.A; ruta nacional no. 9, km 280; parque industrial micropi; alvear, santa fe 2130 ; AR 2130
• Manufacturer (Section G): TERRAGENE S.A; ruta nacional no. 9, km 280; parque industrial micropi; alvear, santa fe 2130 ; AR 2130
• Manufacturer Contact: hernando carrizo ; ruta nacional no. 9, km 280; parque industrial micropi; alvear, santa fe 2130 ; AR 2130
• MDR Report Key: 18474940
• MDR Text Key: 332892833
• Report Number: 3013145340-2024-00017
• Device Sequence Number: 1
• Product Code: FRC
• UDI-Device Identifier: 07798164678175
• UDI-Public: 07798164678175
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/09/2024

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
• Device Model Number: STRYKER SLCD12
• Device Lot Number: SLCD124820
• Initial Date Manufacturer Received: 03/15/2023
• Initial Date FDA Received: 01/09/2024
• Date Device Manufactured: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1