MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SC+ QBL SOFTWARE; COUNTER, SPONGE, SURGICAL

Catalog Number	0894000005
Medical Device Problem Code	High Readings (2459)
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.Additional information: 2 devices were not reprocessed or reused.
Event or Problem Description
This report summarizes 2 events for the failure: high 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 # 3015967359-2025-99253.Supplemental rationale, corrected data: b5, h1, h6, h11.2 events were previously reported during the reporting quarter: however, - 1 previously reported event was included under mfr report # vmsr - 0894000005 - 1535 but should be included under this report.- 3 previously reported events are included in this follow-up record.Product return status.2 devices were not available for evaluation.1 device investigation type has not yet been determined.Evaluation findings (results/components).2 devices: no findings available / part/component/sub-assembly term not applicable.1 device: results pending completion of investigation / part/component/sub-assembly term not applicable.Product disposition.2 devices: product not received.1 device: product disposition is not yet determined.
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 april 1 ¿ june 30, 2025.This report summarizes 3 events for the failure: high readings.- 3 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 # 3015967359-2025-99253.Supplemental rationale: corrected data: b5, h6, h11.3 previously reported events were included in this follow-up record.Product return status: 3 devices were not available for evaluation.Evaluation findings (results/components): 3 devices: no findings available / part/component/sub-assembly term not applicable.Product disposition: 3 devices: product not received.
Event or Problem Description
No change.

• Brand Name: SC+ QBL SOFTWARE
• Common Device Name: COUNTER, SPONGE, SURGICAL
• 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: 22648141
• Report Number: 3015967359-2025-99253
• Device Sequence Number: 21002163
• Product Code: LWH
• UDI-Device Identifier: 07613327622799
• UDI-Public: 07613327622799
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 3
• 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): 01/29/2026

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: 0894000005
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/30/2025
• Supplement Date Received by Manufacturer: 06/30/2025; 06/30/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 10/30/2025; 01/29/2026
• 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