FDA Adverse Event
Malfunction
Summary report: N
RETRACTOR
MDR report key: 8458941
·
Received March 28, 2019
Report
- Report Number
- 8458941
- Event Type
- Malfunction
- Date Received
- March 28, 2019
- Date of Event
- March 26, 2019
- Report Date
- March 27, 2019
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- DWS
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- PA
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
THE ESTECH RETRACTOR (CAT# 401-1610 SERIAL NUMBER (B)(4)) FELL APART WHILE BEING USED FOR THE PROCEDURE. A CHEST X-RAY WAS TAKEN AT APPROXIMATELY 4:30 AM AND REPORT RECEIVED AT 5:56 AM; REPORT WAS NEGATIVE.
Description of Event or Problem · 1
THE ESTECH RETRACTOR (CAT# 401-1610; SERIAL NUMBER (B)(4)) FELL APART WHILE BEING USED FOR THE PROCEDURE. A CHEST X-RAY WAS TAKEN AT APPROXIMATELY 4:30 AM AND REPORT RECEIVED AT 5:56 AM; REPORT WAS NEGATIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 252502 | RETRACTOR | INSTRUMENTS, SURGICAL, CARDIOVASCULAR | DWS | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 401-1610 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26280 DA |