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	0631-018-180
Medical Device Problem Codes	False Positive Result (1227); Illegible Information (4050)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: a full udi is not available due to missing information (lot number).
Event or Problem Description
Per the account, a sponge was not able to be scanned from a wound pack procedure, which could have resulted in a sponge being retained.The procedure was completed successfully without a 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 was not available for evaluation.
Event or Problem Description
Per the account, a sponge was not able to be scanned from a wound pack procedure, which could have resulted in a sponge being retained.The procedure was completed successfully without a delay; no medical intervention or adverse consequences were reported.

• 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: 20343193
• Report Number: 3015967359-2024-01862
• Device Sequence Number: 7842240
• Product Code: GDY
• UDI-Device Identifier: 57613327512804
• UDI-Public: (01)57613327512804
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 03/10/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 0631-018-180
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/03/2024
• Supplement Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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