MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SURGICOUNT+ GAUZE, 8X4, 12 PLY, RFID, DOUBLE XRAY; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Catalog Number	0622-284-120
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During a robotics procedure, a 12ply 8x4 sponge was placed inside the abdomen through an 8mm trocar.The sponge was removed, and 15 minutes later, it was discovered that the rfid strip had fallen off and was inside the patient.The rfid strip was removed during the procedure, but the patient was not closed.The procedure was completed successfully without a surgical delay; no medical intervention or adverse consequences were reported.

• Brand Name: SURGICOUNT+ GAUZE, 8X4, 12 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: 20140724
• Report Number: 3015967359-2024-01770
• Device Sequence Number: 20687134
• Product Code: GDY
• UDI-Device Identifier: 57613327512538
• UDI-Public: 57613327512538
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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
• Report Date (Section B): 09/04/2024

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: 0622-284-120
• Device Lot Number: 110405
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 09/04/2024
• 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