SURGICOUNT+ GAUZE, 4X4 16 PLY, RFID, DOUBLE XRAY

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 INVESTIGATION TYPE HAS NOT YET BEEN DETERMINED. ADDITIONAL INFORMATION: 1 DEVICE WAS NOT REPROCESSED OR REUSED.

Description of Event or Problem

THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: MATERIAL FRAYED. 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

Additional Manufacturer Narrative

THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. MFR REPORT # 3015967359-2025-99243. SUPPLEMENTAL RATIONALE, CORRECTED DATA: B5, H6, H11, 1 PREVIOUSLY REPORTED EVENTS WERE INCLUDED IN THIS FOLLOW-UP RECORD. PRODUCT RETURN STATUS, 1 DEVICE WAS NOT AVAILABLE FOR EVALUATION. EVALUATION FINDINGS (RESULTS/COMPONENTS), 1 DEVICE: NO FINDINGS AVAILABLE / PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE. PRODUCT DISPOSITION, 1 DEVICE: PRODUCT NOT RECEIVED.

Description of Event or Problem

THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN APRIL 1 ¿ JUNE 30, 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: MATERIAL FRAYED. - 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.