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

Catalog Number	GAUS-2
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During a procedure with hemorrhaging, the quantitative blood loss was significantly lower than the estimated blood loss on the device.The procedure was completed successfully without a 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 log files were not available for evaluation.
Event or Problem Description
No new information.

• Brand Name: TRITON CANISTER
• 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: 20305511
• Report Number: 3015967359-2024-01840
• Device Sequence Number: 8866831
• Product Code: PBZ
• UDI-Device Identifier: 00859506006029
• UDI-Public: (01)00859506006029
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 07/07/2025

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: GAUS-2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/28/2024
• Supplement Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown