FDA Adverse Event
Malfunction
Summary report: N
STRYKER SUSTAINABILITY SOLUTIONS, INC.
MDR report key: 17720430
·
Received September 11, 2023
Report
- Report Number
- 17720430
- Event Type
- Malfunction
- Date Received
- September 11, 2023
- Date of Event
- August 17, 2023
- Report Date
- September 7, 2023
- Manufacturer
- STRYKER SUSTAINABILITY SOLUTIONS, INC.
- Product Code
- NUJ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
PATIENT SAFETY DEPARTMENT IN RECEIPT OF MALFUNCTIONED DEVICE "BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER WITHOUT NANO-COATING". PROCEDURE COMPLETED WAS LAPAROSCOPIC BILATERAL SALPINGECTOMY FOR TUBAL STERILIZATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 150329 | STRYKER SUSTAINABILITY SOLUTIONS, INC. | ELECTROSURGICAL,CUTTING & COAGULATION ACCESSORIES,LAPAROSCOPIC & ENDOSCOPIC,REP | NUJ | STRYKER SUSTAINABILITY SOLUTIONS, INC. | LF1837 | 14891652 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12045 DA | Unknown |