MAUDE Adverse Event Report: TERRAGENE S.A. STRYKER SLCD12; AUTO-READER

Model Number STRYKER SLCD12

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 06/24/2022

Event Type  malfunction  

Event Description

According to the distributor representative, the autoreader incubator would not boot up, since it was stuck in the loading screen.

Manufacturer Narrative

No device-related deaths or serious injuries were informed.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 due to lack of sterile material.

• Brand Name: STRYKER SLCD12
• Type of Device: AUTO-READER
• Manufacturer (Section D): TERRAGENE S.A.; ruta nac. no 9, km 280; parque industrial micropi; alvear, santa fe 2130 ; AR 2130
• Manufacturer (Section G): TERRAGENE S.A.; ruta nac. no 9, km 280; parque industrial micropi; alvear, santa fe 2130 ; * 2130
• Manufacturer Contact: hernando carrizo ; ruta nac. n[?] 9, km 280; parque industrial micropi; alvear, santa fe 2130 ; AR 2130
• MDR Report Key: 18418819
• MDR Text Key: 331604787
• Report Number: 3013145340-2023-00016
• Device Sequence Number: 1
• Product Code: FRC
• UDI-Device Identifier: 07798164678175
• UDI-Public: 07798164678175
• Combination Product (y/n): N
• 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: 12/29/2023

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 Operator: Health Professional
• Device Model Number: STRYKER SLCD12
• Device Lot Number: SLCD124820
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/24/2022
• Initial Date FDA Received: 12/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1