MAUDE Adverse Event Report: TERRAGENE S.A STRYKER SLCD12; INCUBATOR

Model Number STRYKER SLCD12

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 01/05/2022

Event Type  malfunction  

Manufacturer Narrative

There is no evidence of an adverse event or product malfuction.The positive readout may have been caused by an ineffective sterilization process.However, since no further investigation was made, there is a possibility of device malfunction, which may cause the incubator to fail to perform its essential function and compromise the sterilization process monitoring effectiveness which could contribute to delay patient treatment.

Event Description

It was reported that one of the incubator wells was giving false positive readouts of the biological indicators.

• Brand Name: STRYKER SLCD12
• Type of Device: 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: 18394590
• MDR Text Key: 331334843
• Report Number: 3013145340-2023-00005
• Device Sequence Number: 1
• Product Code: FRC
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K191021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/26/2023

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 Model Number: STRYKER SLCD12
• Device Lot Number: SLCD120821
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/01/2022
• Initial Date FDA Received: 12/26/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/02/2021
• 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