MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP TRITON 3L CANISTER INSERT KIT; IMAGE PROCESSING DEVICE FOR ESTIMATION OF EXTERNAL BLOOD LOSS

Catalog Number	FG-12022
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Per the account, during a case the device showed an estimated blood loss lower than expected.The device reflected blood loss readings of 230ml, 411ml, and 200ml.The surgeon felt the blood loss should be around 800ml.The procedure was completed successfully without a surgical delay; no medical intervention or adverse consequences were reported.
Event or Problem Description
Per the account, during a case the device showed an estimated blood loss lower than expected.The device reflected blood loss readings of 230ml, 411ml, and 200ml.The surgeon felt the blood loss should be around 800ml.The procedure was completed successfully without a surgical delay; no medical intervention or adverse consequences were reported.
Additional Manufacturer Narrative
Update: d9, h3, h6 correction: follow-up report submitted to document the device was not available for evaluation.The full udi number is not available due to the missing lot number.

• Brand Name: TRITON 3L CANISTER INSERT KIT
• Common Device Name: IMAGE PROCESSING DEVICE FOR ESTIMATION OF EXTERNAL BLOOD LOSS
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: kelsey barla ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 19338193
• Report Number: 3015967359-2024-01057
• Device Sequence Number: 12934947
• Product Code: PBZ
• UDI-Device Identifier: 10859506006255
• UDI-Public: (01)10859506006255
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K163507
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2024

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 Catalogue Number: FG-12022
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown