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

Catalog Number	0694-002-010
Medical Device Problem Codes	Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the user facility, the circulating nurse closed the case before performing her final sponge count.Since it was a hip procedure, x ray was called into the room to scan the patient when the sponge was found.An additional procedure was performed to remove the sponge.The additional procedure was completed successfully without a clinically significant delay; no medical intervention or adverse consequences were reported.
Additional Manufacturer Narrative
Update: d9, h3, h6.Correction: follow-up report submitted to document the device log files and device were not available for evaluation.
Event or Problem Description
Per the user facility, the circulating nurse closed the case before performing her final sponge count.Since it was a hip procedure, x ray was called into the room to scan the patient when the sponge was found.An additional procedure was performed to remove the sponge.Per additional information, the device was not used to count the sponges out.The user facility has no further information on the reported event.The additional procedure was completed successfully without a clinically significant delay; no medical intervention or adverse consequences were reported.

• Brand Name: SURGICOUNT+ SPONGE COUNTING BAG
• 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: 22372936
• Report Number: 3015967359-2025-01194
• Device Sequence Number: 8091501
• Product Code: LWH
• UDI-Device Identifier: 57613327519506
• UDI-Public: (01)57613327519506
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 11/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 0694-002-010
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/05/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 11/18/2025
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown