FDA Adverse Event
Malfunction
Summary report: N
HIGH FLOW TRAUMA TIP WITH SOFT CONE SPLASH SHIELD
MDR report key: 3130405
·
Received May 24, 2013
Report
- Report Number
- 0001811755-2013-01200
- Event Type
- Malfunction
- Date Received
- May 24, 2013
- Date of Event
- April 26, 2013
- Report Date
- January 10, 2025
- Manufacturer
- STRYKER INSTRUMENTS-PUERTO RICO
- Product Code
- FQH
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MY
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
(B)(4): DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE HIGH FLOW TRAUMA TIP WITH SOFT CONE SPLASH SHIELD WAS BEING USED IN A PROCEDURE WITH A SURGILAV HANDPIECE WHEN IT LOST FUNCTION. THE PROCEDURE WAS DELAYED 30 MINUTES AND WAS COMPLETED SUCCESSFULLY WITH NO PATIENT OR USER INJURIES, AND NO ADVERSE CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 232253 | HIGH FLOW TRAUMA TIP WITH SOFT CONE SPLASH SHIELD | LAVAGE, JET | FQH | STRYKER INSTRUMENTS-PUERTO RICO | R11308012 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |