MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SURGICOUNT+ SAFE-T-LAP SPONGE, 18X18, RFID, ENHANCED XRAY; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Catalog Number	0621018180
Medical Device Problem Code	Detachment of Device or Device Component (2907)
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: 1 event was reported for this quarter.Product return status: 1 device was evaluated using data provided by the user or third party.Evaluation findings (results/components): 1 device: wear problem / connector/coupler product disposition: 1 device: returned to supplier / vendor additional information: 1 device was labeled for single-use, 1 device was 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 1 event for the failure: detachment of device or device component - 1 event had no health consequences or impact.

• Brand Name: SURGICOUNT+ SAFE-T-LAP SPONGE, 18X18, RFID, ENHANCED 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: 23368316
• Report Number: 3015967359-2025-99272
• Device Sequence Number: 10122532
• Product Code: GDY
• UDI-Device Identifier: 07613327512717
• UDI-Public: 07613327512717
• 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
• Report Date (Section B): 10/23/2025

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
• Device Catalogue Number: 0621018180
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 10/23/2025
• 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