LAP SPNG, 18X18, STRL
Received Jul 29, 2025
Report 3015967359-2025-99149 · MDR key 22647042
Device
Generic name
Gauze/sponge, Internal, X-ray Detectable
Manufacturer
Stryker Instruments-a Division Of Stryker CorpCatalog number
0611018180
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. REPORTED EVENTS: 1 EVENT WAS REPORTED FOR THIS QUARTER. PRODUCT RETURN STATUS: 1 DEVICE WAS RECEIVED. 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 # 3015967359-2025-99149. SUPPLEMENTAL RATIONALE, CORRECTED DATA: B5, H6, H11, 1 PREVIOUSLY REPORTED EVENTS WERE INCLUDED IN THIS FOLLOW-UP RECORD. PRODUCT RETURN STATUS, 1 DEVICE WAS RECEIVED. EVALUATION FINDINGS (RESULTS/COMPONENTS), 1 DEVICE: WEAR PROBLEM / FIBER. PRODUCT DISPOSITION, 1 DEVICE: SCRAPPED BY STRYKER.
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.