SURGICAL TABLET 3.0
Received Apr 22, 2026
Report 3015967359-2026-99221 · MDR key 24953965
Device
Generic name
Image Processing Device For Estimation Of External Blood Loss
Manufacturer
Stryker Instruments-a Division Of Stryker CorpCatalog number
0894001000
Product problems
- Low Readings
Patient
NA · Unknown
- 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 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. ADDITIONAL INFORMATION: 1 DEVICE WAS NOT 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 (B)(6) ¿ (B)(6) 2026. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: LOW READINGS. 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.