SURGICOUNT+ GAUZE, 8X4, 16 PLY, RFID, DOUBLE XRAY
Received Jul 29, 2025
Report 3015967359-2025-99187 · MDR key 22647255
Device
Generic name
Gauze/sponge, Internal, X-ray Detectable
Manufacturer
Stryker Instruments-a Division Of Stryker CorpCatalog number
0622284160
Product problems
- Material Frayed
- Material Frayed
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. MFR REPORT # 3015967359-2025-99187. SUPPLEMENTAL RATIONALE. CORRECTED DATA: B5, H6, H11. 2 PREVIOUSLY REPORTED EVENTS WERE INCLUDED IN THIS FOLLOW-UP RECORD. PRODUCT RETURN STATUS 2 DEVICES WERE NOT AVAILABLE FOR EVALUATION. EVALUATION FINDINGS (RESULTS/COMPONENTS) 2 DEVICES: NO FINDINGS AVAILABLE / PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE. PRODUCT DISPOSITION 2 DEVICES: PRODUCT NOT RECEIVED.
Description of Event or Problem
NO CHANGE.
Description of Event or Problem
THIS REPORT SUMMARIZES 2 EVENTS FOR THE FAILURE: MATERIAL FRAYED. 2 EVENTS 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. REPORTED EVENTS: 2 EVENTS WERE REPORTED FOR THIS QUARTER. PRODUCT RETURN STATUS: 2 DEVICES HAD INVESTIGATION TYPES THAT HAVE NOT YET BEEN DETERMINED. ADDITIONAL INFORMATION: 2 DEVICES WERE NOT REPROCESSED OR REUSED.
Additional Manufacturer Narrative
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. MFR REPORT # 3015967359-2025-99187. SUPPLEMENTAL RATIONALE, CORRECTED DATA: B5, H6, H11. 2 PREVIOUSLY REPORTED EVENTS WERE INCLUDED IN THIS FOLLOW-UP RECORD. PRODUCT RETURN STATUS, 1 DEVICE INVESTIGATION TYPE HAS NOT YET BEEN DETERMINED. 1 DEVICE WAS NOT AVAILABLE FOR EVALUATION. EVALUATION FINDINGS (RESULTS/COMPONENTS). 1 DEVICE: RESULTS PENDING COMPLETION OF INVESTIGATION / PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE. 1 DEVICE: NO FINDINGS AVAILABLE / PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE. PRODUCT DISPOSITION. 1 DEVICE: PRODUCT NOT RECEIVED. 1 DEVICE: PRODUCT DISPOSITION IS NOT YET DETERMINED.
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 2 EVENTS FOR THE FAILURE: MATERIAL FRAYED. - 2 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.