MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SURGICOUNT+ GAUZE, 4X4 16 PLY, RFID, DOUBLE XRAY; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Catalog Number	0632244160
Medical Device Problem Code	Delivered as Unsterile Product (1421)
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 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 july 1 ¿ september 30, 2025.This report summarizes 2 events for the failure: delivered as unsterile product, 1 event had no health consequences or impact, 1 event 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 # 3015967359-2025-99400.Supplemental rationale: corrected data: b5, h1, h6, h11.2 events were previously reported during the reporting quarter; however, 1 event was reported in error.1 previously reported event is included in this follow-up record.Product return status: 1 device investigation type has not yet been determined.Evaluation findings (results/components): 1 device: results pending completion of investigation / part/component/sub-assembly term not applicable.Product disposition: 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 july 1 ¿ september 30 2025.This report summarizes 1 event for the failure: delivered as unsterile product.- 1 event 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 # 3015967359-2025-99400.Supplemental rationale: corrected data: b5, h6, h11.1 previously reported event was included in this follow-up record.Product return status: 1 device was received.Evaluation findings (results/components): 1 device: manufacturing process problem identified / packaging.Product disposition: 1 device: returned to supplier / vendor.
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 july 1 ¿ september 30 2025.This report summarizes 1 event for the failure: delivered as unsterile product.- 1 event had problem identified before clinical use/exposure; there was no patient involvement.

• Brand Name: SURGICOUNT+ GAUZE, 4X4 16 PLY, RFID, DOUBLE XRAY
• Common Device Name: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• 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: 23399856
• Report Number: 3015967359-2025-99400
• Device Sequence Number: 10015405
• Product Code: GDY
• UDI-Device Identifier: 07613327512649
• UDI-Public: 07613327512649
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 1
• 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): 04/24/2026

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: 0632244160
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/30/2025
• Supplement Date Received by Manufacturer: 09/30/2025; 09/30/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 01/27/2026; 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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