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

Model Number	STRYKER SLCD12
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that one of the incubator wells was giving false positive readouts of the biological indicators.

• Brand Name: STRYKER SLCD12
• Common Device Name: 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
• Report Number: 3013145340-2023-00005
• Device Sequence Number: 16831337
• Product Code: FRC
• UDI-Device Identifier: 07798164678175
• UDI-Public: 07798164678175
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K191021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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 Expiration Date: 03/02/2026
• Device Model Number: STRYKER SLCD12
• Device Lot Number: SLCD120821
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2022
• Initial Report FDA Received Date: 12/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/02/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown