SURGICOUNT+ SAFE-T-LAP SPONGE, 18X18, RFID, ENHANCED XRAY
Received Oct 23, 2025
Report 3015967359-2025-99272 · MDR key 23368316
Device
Generic name
Gauze/sponge, Internal, X-ray Detectable
Manufacturer
Stryker Instruments-a Division Of Stryker CorpCatalog number
0621018180
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
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. REPORTED EVENTS: 1 EVENT WAS REPORTED FOR THIS QUARTER. PRODUCT RETURN STATUS: 1 DEVICE WAS EVALUATED USING DATA PROVIDED BY THE USER OR THIRD PARTY. EVALUATION FINDINGS (RESULTS/COMPONENTS): 1 DEVICE: WEAR PROBLEM / CONNECTOR/COUPLER PRODUCT DISPOSITION: 1 DEVICE: RETURNED TO SUPPLIER / VENDOR ADDITIONAL INFORMATION: 1 DEVICE WAS LABELED FOR SINGLE-USE, 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 JULY 1 ¿ SEPTEMBER 30 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: DETACHMENT OF DEVICE OR DEVICE COMPONENT - 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.