SURGICOUNT+ GAUZE, 4X4 16 PLY, RFID, DOUBLE XRAY
Received Oct 22, 2024 · Event occurred Sep 30, 2024
Report 3015967359-2024-02199 · MDR key 20504492
Device
Generic name
Gauze/sponge, Internal, X-ray Detectable
Manufacturer
Stryker Instruments-a Division Of Stryker CorpCatalog number
0632-244-160
Lot number
VMSR
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. SUPPLEMENTAL RATIONALE CORRECTED DATA: H6, H11 2 PREVIOUSLY REPORTED EVENTS ARE INCLUDED IN THIS FOLLOW-UP RECORD. PRODUCT RETURN STATUS 2 DEVICES WERE NOT AVAILABLE FOR EVALUATION.
Description of Event or Problem
THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE MATERIAL REPORTEDLY FRAYED. - 2 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT 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: 1 DEVICE WAS NOT AVAILABLE FOR EVALUATION. 1 DEVICE INVESTIGATION TYPE HAS NOT YET BEEN DETERMINED. ADDITIONAL INFORMATION: 2 DEVICES WERE LABELED FOR SINGLE-USE. 2 DEVICES WERE NOT REPROCESSED OR REUSED.
Description of Event or Problem
THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE MATERIAL REPORTEDLY FRAYED. - 2 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.