SC+ QBL SOFTWARE
Report
- Report Number
- 3015967359-2025-99131
- Event Type
- Malfunction
- Date Received
- July 29, 2025
- Report Date
- October 29, 2025
- Manufacturer
- STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
- Product Code
- LWH
- UDI-DI
- 07613327622799
- 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. 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. SUPPLEMENTAL RATIONALE: CORRECTED DATA: B5, H1, H6, H11. 1 EVENT WAS PREVIOUSLY REPORTED DURING THE REPORTING PERIOD: HOWEVER, 1 PREVIOUSLY REPORTED EVENT IN THIS REPORT SHOULD HAVE BEEN INCLUDED UNDER MFR REPORT # 3015967359-2025-99253. 0 PREVIOUSLY REPORTED EVENTS ARE INCLUDED IN THIS FOLLOW-UP RECORD.
THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: INCORRECT, INADEQUATE OR IMPRECISE RESULT OR READINGS. 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.
THIS REPORT SUMMARIZES 0 EVENTS FOR THE FAILURE: INCORRECT, INADEQUATE OR IMPRECISE RESULT OR READINGS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1096554 | SC+ QBL SOFTWARE | COUNTER, SPONGE, SURGICAL | LWH | STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP | 07613327622799 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |