TRITON SPONGE
Report
- Report Number
- 3011157718-2023-00193
- Event Type
- Malfunction
- Date Received
- April 28, 2023
- Date of Event
- September 25, 2017
- Report Date
- July 21, 2023
- Manufacturer
- STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
- Product Code
- PBZ
- PMA / PMN Number
- K163507
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ADDITIONAL INFORMATION: FOR BACKGROUND, STRYKER ACQUIRED GAUSS SURGICAL INC. (¿GAUSS¿) ON SEPTEMBER 1, 2021. THE MAJORITY OF THE LATE MDRS RESULTED FROM A RETROSPECTIVE REVIEW OF REPORTABILITY DECISIONS MADE PRIOR TO THE ACQUISITION. ADDITIONALLY, STRYKER HAS DETERMINED THAT A CAPA IS NEEDED TO IMPROVE THE POST-ACQUISITION COMPLAINT REVIEW PROCESS ¿ AS A RESULT, CAPA #3338129 WAS APPROVED ON JUNE 14, 2023 AND OPENED ON JUNE 19.
PER THE CUSTOMER, THE CANISTER WAS AT ABOUT 2200 VOLUME OF A 3-LITER CANISTER. IT CAME BACK AS OVER SATURATED. CUSTOMER STATED THAT FLUID WAS ADDED TO FULL AND IT STILL WAS OVER SATURATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
PER THE CUSTOMER, THE CANISTER WAS AT ABOUT 2200 VOLUME OF A 3-LITER CANISTER. IT CAME BACK AS OVER SATURATED. CUSTOMER STATED THAT FLUID WAS ADDED TO FULL AND IT STILL WAS OVER SATURATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1164160 | TRITON SPONGE | IMAGE PROCESSING DEVICE FOR ESTIMATION OF EXTERNAL BLOOD LOSS | PBZ | STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |