SURGICOUNT+ SAFE-T-LAP SPONGE, 18X18, RFID, ENHANCED XRAY
Received Jul 29, 2025
Report 3015967359-2025-99216 · MDR key 22647331
Device
Generic name
Gauze/sponge, Internal, X-ray Detectable
Manufacturer
Stryker Instruments-a Division Of Stryker CorpCatalog number
0621018180
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 # 3015967359-2025-99216. SUPPLEMENTAL RATIONALE: CORRECTED DATA: B5, H6, H11. 1 PREVIOUSLY REPORTED EVENT WAS 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
NO CHANGE.
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. 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 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.
Additional Manufacturer Narrative
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. MFR REPORT # 3015967359-2025-99216. SUPPLEMENTAL RATIONALE CORRECTED DATA: B5, H11 1 PREVIOUSLY REPORTED EVENTS WERE INCLUDED IN THIS FOLLOW-UP RECORD. PRODUCT RETURN STATUS: 1 DEVICE INVESTIGATION TYPE HAS NOT YET BEEN DETERMINED. EVALUATION FINDINGS (RESULTS/COMPONENTS) 1 DEVICE: RESULTS PENDING COMPLETION OF INVESTIGATION / PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE. PRODUCT DISPOSITION: 1 DEVICE: PRODUCT DISPOSITION IS NOT YET DETERMINED.