TRITON CANISTER
Report
- Report Number
- 3011157718-2023-00209
- Event Type
- Malfunction
- Date Received
- April 27, 2023
- Date of Event
- July 26, 2017
- Report Date
- July 21, 2023
- Manufacturer
- STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
- Product Code
- PBZ
- PMA / PMN Number
- K142801
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, 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, FOUND A CASE WITH A CANISTER WITH A VOLUME OF 600 ML OF FAIRLY SATURATED FLUID. THE IMAGING SURFACE OF INSERT WAS COMPLETELY WHITE. NONE OF THE FLUID EGRESSED INTO THE IMAGING SPACE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
PER THE CUSTOMER, FOUND A CASE WITH A CANISTER WITH A VOLUME OF 600 ML OF FAIRLY SATURATED FLUID. THE IMAGING SURFACE OF INSERT WAS COMPLETELY WHITE. NONE OF THE FLUID EGRESSED INTO THE IMAGING SPACE. 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 |
|---|---|---|---|---|---|---|---|
| 1235623 | TRITON CANISTER | 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 |