MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SC+ AI SOFTWARE; IMAGE PROCESSING DEVICE FOR ESTIMATION OF EXTERNAL BLOOD LOSS

Catalog Number	0894000004
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 2 events were reported for this quarter.Product return status: 2 devices had investigation types that have not yet been determined.Evaluation findings (results/components): 2 devices: results pending completion of investigation / part/component/sub-assembly term not applicable.Product disposition: 2 devices: product disposition is not yet determined.Additional information: 2 devices were not labeled for single-use.2 devices were not reprocessed or reused.
Event or Problem Description
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Events occurred between october 1 ¿ december 31, 2025.This report summarizes 2 events for the failure: low readings.2 events had no health consequences or impact.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Mfr report # 3015967359-2026-99121.Supplemental rationale corrected data: b5, h6, h11.2 previously reported events were included in this follow-up record.Product return status 1 device was not available for evaluation.1 device investigation type has not yet been determined.Evaluation findings (results/components) 1 device: no device problem found / part/component/sub-assembly term not applicable.1 device: results pending completion of investigation / part/component/sub-assembly term not applicable.Product disposition 1 device: product not received.1 device: product disposition is not yet determined.
Event or Problem Description
No change.

• Brand Name: SC+ AI SOFTWARE
• 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: 24163748
• Report Number: 3015967359-2026-99121
• Device Sequence Number: 9129280
• Product Code: PBZ
• UDI-Device Identifier: 07613327622782
• UDI-Public: 07613327622782
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 2
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/08/2026

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 Catalogue Number: 0894000004
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/31/2025
• Supplement Date Received by Manufacturer: 12/31/2025; 12/31/2025
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 04/24/2026; 06/08/2026
• 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