TRITON CANISTER
Report
- Report Number
- 3011157718-2023-00047
- Event Type
- Malfunction
- Date Received
- April 28, 2023
- Date of Event
- June 27, 2019
- 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
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
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, THEY ARE GETTING READINGS FROM THE SUCTION CANISTERS IN THE OR OF 10CC QBL AND A COUPLE MORE OF <100CC OF QBL. ONE OF THOSE HAD A DROP IN HEMOGLOBIN OF 2 PT. PER THE CUSTOMER THE ACCURACY DOES NOT SEEM ACCURATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
PER THE CUSTOMER, THEY ARE GETTING READINGS FROM THE SUCTION CANISTERS IN THE OR OF 10CC QBL AND A COUPLE MORE OF <100CC OF QBL. ONE OF THOSE HAD A DROP IN HEMOGLOBIN OF 2 PT. PER THE CUSTOMER THE ACCURACY DOES NOT SEEM ACCURATE. 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 |
|---|---|---|---|---|---|---|---|
| 1335736 | 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 |