FDA Adverse Event
Malfunction
Summary report: N
GENISTRONG
MDR report key: 10243044
·
Received July 7, 2020
Report
- Report Number
- 3002590791-2020-00028
- Event Type
- Malfunction
- Date Received
- July 7, 2020
- Date of Event
- February 13, 2018
- Report Date
- July 7, 2020
- Manufacturer
- GENICON, INC.
- Product Code
- GCJ
- UDI-DI
- 00877972004004
- PMA / PMN Number
- K180836
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 1
THIS REPORTABLE EVENT WAS IDENTIFIED DURING A REVIEW OF COMPLAINT FILES RECEIVED BETWEEN (B)(6) 2017 AND (B)(6) 2019. NO PHYSICAL OR VISUAL EVALUATION COULD BE PERFORMED; COMPLAINANT DID NOT TAKE PHOTOGRAPHS AND DID NOT KEEP THE SAMPLE FOR RETURN. A ROOT CAUSE COULD NOT BE DETERMINED.
Description of Event or Problem · 1
THE RIP-STOP NYLON STRIP CONTAINING CINCHING STRING CAME DETACHED FROM THE SPECIMEN RETRIEVAL BAG AND POINT OF CONNECTION TO THE BAG. THE SPECIMEN RETRIEVAL BAG FELL INTO PATIENT'S ABDOMEN AND WAS RETRIEVED BY THE SURGEON USING A GRASPER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 706031 | GENISTRONG | SPECIMEN RETRIEVAL BAG | GCJ | GENICON, INC. | 550-000-003 | I9074 | 00877972004004 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |