FDA Adverse Event
Malfunction
Summary report: N
GENICON GENISURGE
MDR report key: 10387825
·
Received August 10, 2020
Report
- Report Number
- 3002590791-2020-00081
- Event Type
- Malfunction
- Date Received
- August 10, 2020
- Date of Event
- January 10, 2018
- Report Date
- August 10, 2020
- Manufacturer
- GENICON, INC.
- Product Code
- GCJ
- UDI-DI
- 00877972006916
- PMA / PMN Number
- K061417
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 1
THIS REPORTABLE EVENT WAS IDENTIFIED DURING A REVIEW OF COMPLAINT FILES BETWEEN (B)(6) 2017 THROUGH (B)(6) 2019.
Description of Event or Problem · 1
A FAULTY ENDOCLINCH PRODUCT, 1 533-005-945 OPENED YESTERDAY IN THE THEATRE, WHICH FELL APART ON INSERTION INTO THE ABDOMEN, THE PARTS WERE SUCCESSFULLY RETRIEVED AND A DATIX COMPLETED. ITEM WAS ISOLATED FOR EXAMINATION, ALL OTHER ITEMS FROM THAT BATCH WERE REMOVED FROM STORE AND ARE IN THE THEATRE CONTROLLER'S OFFICE AWAITING FURTHER ADVICE, IT WAS A LAP COLORECTAL PROCEDURE, IT HAPPENED WITH 2 OF THE CLINCHES FROM THE SAME LOT, ONLY ONE RETURNED AS THE OTHER WAS CONTAMINATED. NO STAPLES OR CLIPS WERE IN THE WAY AT THE TIME, IT HAPPENED IMMEDIATELY AFTER THE INSTRUMENT WAS INSERTED INTO THE ABDOMEN WHEN THEY OPENED THE JAWS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 848704 | GENICON GENISURGE | SINGLE-USE MONOPOLAR INSTRUMENT | GCJ | GENICON, INC. | 533-005-945 | I60556-B | 00877972006916 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |