SURGICAL TABLET 3.0
Report
- Report Number
- 3015967359-2025-99148
- Event Type
- Malfunction
- Date Received
- July 29, 2025
- Report Date
- January 29, 2026
- Manufacturer
- STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
- Product Code
- PBZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. MFR REPORT # 3015967359-2025-99148. 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.
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.
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. MFR REPORT # 3015967359-2025-99148. 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 DEVICE PROBLEM FOUND / PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE. PRODUCT DISPOSITION: 1 DEVICE: PRODUCT NOT RECEIVED.
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN (B)(6) 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: LOW READINGS. 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.
THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: LOW READINGS. 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.
NO CHANGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 861245 | SURGICAL TABLET 3.0 | IMAGE PROCESSING DEVICE FOR ESTIMATION OF EXTERNAL BLOOD LOSS | PBZ | STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |