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

Catalog Number	0894-000-003
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that during a case, sponges were scanned in and then out, an error occurred and the case reported none of the sponges were scanned out.An x-ray was taken to confirm no sponges were retained.No adverse consequences or additional medical intervention was taken.

• Brand Name: SC+ SPONGE COUNTING 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: 24279483
• Report Number: 3015967359-2026-00076
• Device Sequence Number: 15598424
• Product Code: LWH
• UDI-Device Identifier: 07613327622751
• UDI-Public: (01)07613327622751
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,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
• Operator of Device: Health Professional
• Device Catalogue Number: 0894-000-003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2026
• Supplement Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 06/08/2026
• 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