FDA Adverse Event
Malfunction
Summary report: N
ETHICON SECURESTRAP
MDR report key: 10778061
·
Received November 3, 2020
Report
- Report Number
- 10778061
- Event Type
- Malfunction
- Date Received
- November 3, 2020
- Date of Event
- June 24, 2020
- Report Date
- October 20, 2020
- Manufacturer
- ETHICON, LLC
- Product Code
- GDW
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- UT
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 0
ETHICON SECURESTRAP® ABSORBABLE STRAP FIXATION DEVICE STRAP25 WOULD NOT DEPLOY ANY STRAPS DURING THE SURGICAL PROCEDURE. ETHICON, LLC WAS NOT MADE AWARE OF THIS DEVICE UNTIL RECENTLY. ETHICON PROVIDED RGA# AND PRODUCT RETURN PACKAGING FOR THE DEFECTIVE DEVICE.
Description of Event or Problem · 1
ETHICON SECURESTRAP® ABSORBABLE STRAP FIXATION DEVICE STRAP25 WOULD NOT DEPLOY ANY STRAPS DURING THE SURGICAL PROCEDURE. ETHICON, LLC WAS NOT MADE AWARE OF THIS DEVICE UNTIL RECENTLY. ETHICON PROVIDED RGA# AND PRODUCT RETURN PACKAGING FOR THE DEFECTIVE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1244920 | ETHICON SECURESTRAP | STAPLE, IMPLANTABLE | GDW | ETHICON, LLC | STRAP25 | PKK788 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22995 DA |