MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SMARTPUMP DUAL CHANNEL; TOURNIQUET, PNEUMATIC

Catalog Number	5920011000
Medical Device Problem Code	Decrease in Pressure (1490)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Insufficient Information (4580); 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 16 events were reported for this quarter.Product return status 9 devices were received.7 devices had investigation types that have not yet been determined.Evaluation findings (results/components) 5 devices: no device problem found / part/component/sub-assembly term not applicable 2 devices: fatigue problem / connector/coupler 1 device: electrical/electronic component problem identified / circuit board 7 devices: results pending completion of investigation / part/component/sub-assembly term not applicable 1 device: electrical/electronic component problem identified / tube product disposition 9 devices: serviced and returned to customer 7 devices: product disposition is not yet determined additional information 16 devices were not labeled for single-use.16 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 16 events for the failure: decrease in pressure.- 6 events had problem identified before clinical use/exposure; there was no patient involvement.- 5 events had no health consequences or impact.- 3 events had problem identified during non-clinical procedure; there was no patient involvement.- 1 event had insufficient information.- 1 event had minor injury/illness/impairment.
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 2026.This report summarizes 13 events for the failure: decrease in pressure.- 4 events had problem identified before clinical use/exposure; there was no patient involvement.- 6 events had no health consequences or impact.- 3 events had problem identified during non-clinical procedure; there was no patient involvement.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Mfr report # 3015967359-2026-99027.On 2/24/2026 stryker instruments discontinued the practice of filing mdrs for complaints related to decrease in pressure for devices registered under kcy product code in according to fda's "final guidance on medical device reporting for manufacturers" section 2.15.This malfunction has not caused or contributed to any serious injuries or deaths in at least two years.No new mdrs will be filed for this malfunction and corrected supplemental mdrs will be submitted if necessary for any events pending device investigation.Supplemental rationale corrected data: b5, h1, h6, h11 16 events were previously reported during the reporting quarter; however, - 3 events were determined to be not reportable.- 13 previously reported events are included in this follow-up record.Product return status 12 devices were received.1 device was not available for evaluation.Evaluation findings (results/components) 7 devices: no device problem found / part/component/sub-assembly term not applicable 2 devices: fatigue problem / connector/coupler 2 devices: electrical/electronic component problem identified / circuit board 1 device: no findings available / part/component/sub-assembly term not applicable 1 device: electrical/electronic component problem identified / tube.Product disposition 12 devices: serviced and returned to customer 1 device: product not received.

• Brand Name: SMARTPUMP DUAL CHANNEL
• Common Device Name: TOURNIQUET, PNEUMATIC
• 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: 24163096
• Report Number: 3015967359-2026-99027
• Device Sequence Number: 18483956
• Product Code: KCY
• UDI-Device Identifier: 07613154589647
• UDI-Public: 07613154589647
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 13
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2026

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: 5920011000
• 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
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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